Akorn

North America

Canada (2)
X
Product
Pack
Market
Pres.
Dosage
ATC
API
PRESERVATIVE-FREE THERA TEARS LUBRICANT EYE DROPS 0.25% drops
OTC
OPHTHALMIC
S01XA20
THERATEARS LUBRICANT EYE DROPS 0.25% sol
OTC
OPHTHALMIC
S01XA20
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
PRESERVATIVE-FREE THERA TEARS LUBRICANT EYE DROPS 0.25% drops
02242082
THERATEARS LUBRICANT EYE DROPS 0.25% sol
02248854
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United States (298)
X
Product
Pack
Market
Pres.
Dosage
ATC
API
ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML sol
Y
Rx
oral
N02AJ06
ACETYLCYSTEINE 6GM/30ML (200MG/ML) inj
Y
Rx
iv
V03AB23
ACYCLOVIR 200MG/5ML susp
Y
Rx
oral
J05AB01
ADENOSINE 3MG/ML inj
Y
Rx
INJECTION
C01EB10
ADENOSINE 60MG/20ML (3MG/ML) sol
Y
Rx
iv
C01EB10
ADENOSINE 90MG/30ML (3MG/ML) sol
Y
Rx
iv
C01EB10
AK-FLUOR 10% EQ 500MG BASE/5ML (EQ 100MG BASE/ML) inj
Y
Rx
iv
S01JA01
AK-FLUOR 25% EQ 500MG BASE/2ML (EQ 250MG BASE/ML) inj
Y
Rx
iv
S01JA01
AK-PENTOLATE 1% SOLUTION/DROPS
N
ocular
S01FA04
AKBETA 0.25% SOLUTION/DROPS
Y
Rx
ocular
S01ED03
AKBETA 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01ED03
AKPENTOLATE 1% SOLUTION/DROPS
Y
Rx
ocular
S01FA04
AKPENTOLATE 2% SOLUTION/DROPS
N
ocular
S01FA04
AKPRO 0.1% SOLUTION/DROPS
N
ocular
S01EA02
AKTEN 3.5% gel
Y
Rx
ocular
0
AKTOB 0.3% SOLUTION/DROPS
Y
Rx
ocular
S01AA12
ALBUTEROL SULFATE EQ 0.083% BASE sol
N
inh
R03AC02
ALBUTEROL SULFATE EQ 0.5% BASE sol
Y
Rx
inh
R03AC02
ALBUTEROL SULFATE EQ 2MG BASE/5ML syrup
Y
Rx
oral
R03CC02
ALFENTA EQ 0.5MG BASE/ML inj
Y
Rx
INJECTION
N01AH02
AMANTADINE HYDROCHLORIDE 50MG/5ML syrup
Y
Rx
oral
N04BB01
AMICAR inj
N
INJECTION
B02AA01
AMICAR 0.25GM/ML sol
Y
Rx
oral
B02AA01
AMICAR 1GM tabs
Y
Rx
oral
B02AA01
AMICAR 500MG tabs
Y
Rx
oral
B02AA01
AMINOCAPROIC 500MG tabs
N
oral
B02AA01
AMINOCAPROIC ACID 0.25GM/ML sol
N
oral
B02AA01
AMIODARONE HYDROCHLORIDE 50MG/ML inj
N
INJECTION
C01BD01
APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01EA03
ATROPINE SULFATE 1% SOLUTION/DROPS
Y
Rx
ocular
S01FA01
AZASITE 1% SOLUTION/DROPS
Y
Rx
ocular
S01AA26
AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS
Y
Rx
ocular
S01GX07
AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY md spray
Y
Rx
nasal
AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY md spray
Y
Rx
nasal
BACITRACIN 50,000 UNITS/VIAL inj
N
INJECTION
J01XX10
BACITRACIN ZINC AND POLYMYXIN B SULFATE 500 UNITS/GM;10,000 oint
Y
Rx
ocular
0
BAL 10% inj
Y
Rx
INJECTION
V03AB09
BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML sol
Y
Rx
IRRIGATION
???
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE augmented lotion
Y
Rx
topical
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE lotion
Y
Rx
topical
D07AC01
BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED02
BETIMOL EQ 0.25% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED01
BETIMOL EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED01
BIMATOPROST 0.03% SOLUTION/DROPS
N
Y

Rx
topical
S01EE03
BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS
Y
Rx
ocular
S01EA05
BROMFENAC SODIUM EQ 0.09% ACID SOLUTION/DROPS
Y
Rx
ocular
S01BC11
CALCIPOTRIENE 0.005% sol
Y
Rx
topical
D05AX02
CALCITRIOL 0.001MG/ML inj
Y
Rx
INJECTION
A11CC04
CALCITRIOL 0.002MG/ML inj
N
INJECTION
A11CC04
CAPASTAT SULFATE EQ 1GM BASE/VIAL inj
Y
Rx
INJECTION
J04AB30
CARBOPLATIN 150MG/15ML (10MG/ML) inj
Y
Rx
iv
L01XA02
CARBOPLATIN 450MG/45ML (10MG/ML) inj
Y
Rx
iv
L01XA02
CARBOPLATIN 50MG/5ML (10MG/ML) inj
Y
Rx
iv
L01XA02
CARBOPLATIN 600MG/60ML (10MG/ML) inj
Y
Rx
iv
L01XA02
CEFTRIAXONE EQ 1GM BASE/VIAL inj
Y
Rx
iv/im
J01DD04
CEFTRIAXONE EQ 250MG BASE/VIAL inj
Y
Rx
iv/im
J01DD04
CEFTRIAXONE EQ 2GM BASE/VIAL inj
Y
Rx
iv/im
J01DD04
CEFTRIAXONE EQ 500MG BASE/VIAL inj
Y
Rx
iv/im
J01DD04
CHLORAMPHENICOL 0.5% SOLUTION/DROPS
N
ocular
S01AA01
CHLORHEXIDINE GLUCONATE 0.12% sol
Y
Rx
dental
A01AB03
CICLOPIROX 8% sol
Y
Y
Rx
Rx
topical
D01AE14
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML sol
Y
Rx
oral
A02BA01
CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS
Y
Rx
ocular
S01AE03
CLINDAMYCIN PHOSPHATE EQ 1% BASE swab
Y
Rx
topical
D10AF01
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER EQ inj
Y
Rx
INJECTION
J01FF01
CLOBETASOL PROPIONATE 0.05% lotion
N
topical
D07AD01
CLOBETASOL PROPIONATE 0.05% shampoo
Y
Rx
topical
D07AD01
CLOBETASOL PROPIONATE 0.05% spray
Y
Rx
topical
D07AD01
COGENTIN 1MG/ML inj
Y
Rx
INJECTION
N04AC01
COR-OTICIN 1.5%;EQ 3.5MG BASE/ML drops, susp
N
ocular
0
CORMAX 0.05% cream
Y
Rx
topical
D07AD01
COSOPT EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED51
COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED51
CROMOLYN SODIUM 4% SOLUTION/DROPS
Y
Rx
ocular
S01GX01
CYANOCOBALAMIN 1MG/ML inj
N
INJECTION
B03BA01
CYCLOPENTOLATE HYDROCHLORIDE 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01FA04
DEMECLOCYCLINE HYDROCHLORIDE 150MG tabs
Y
Rx
oral
J01AA01
DEMECLOCYCLINE HYDROCHLORIDE 300MG tabs
Y
Rx
oral
J01AA01
DESONIDE 0.05% oint
Y
Rx
topical
D07AB08
DESOXIMETASONE 0.05% gel
Y
Rx
topical
D07AC03
DESOXIMETASONE 0.05% cream
Y
Rx
topical
D07AC03
DESOXIMETASONE 0.25% oint
Y
Rx
topical
D07AC03
DESOXIMETASONE 0.25% cream
Y
Rx
topical
D07AC03
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE SOLUTION/DROPS
N
otic
0
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML inj
N
INJECTION
0
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG inj
Y
Rx
INJECTION
N05CM18
DICLOFENAC SODIUM 0.1% SOLUTION/DROPS
Y
Rx
ocular
S01BC03
DICLOFENAC SODIUM 1.5% sol
Y
Rx
topical
DICLOFENAC SODIUM 1% gel
Y
Rx
topical
DICYCLOMINE HYDROCHLORIDE 10MG/ML inj
Y
Rx
INJECTION
A03AA07
DIFLORASONE DIACETATE 0.05% oint
Y
Rx
topical
D07AC10
DILTIAZEM HYDROCHLORIDE 5MG/ML inj
Y
Rx
INJECTION
C08DB01
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML syrup
N
oral
R06AA02
DIURIL tabs
N
N

oral
C03AA04
DIURIL EQ 500MG BASE/VIAL inj
Y
Rx
INJECTION
C03AA04
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE EQ 2% BASE;EQ SOLUTION/DROPS
Y
Y
Rx
Rx
ocular
S01ED51
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS
Y
Rx
ocular
S01EC03
DOXERCALCIFEROL 2MCG/ML (2MCG/ML) inj
Y
Rx
INJECTION
H05BX03
DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) inj
Y
Rx
INJECTION
H05BX03
DRONABINOL 10MG caps
Y
Rx
oral
A04AD10
DRONABINOL 2.5MG caps
Y
Rx
oral
A04AD10
DRONABINOL 5MG caps
Y
Rx
oral
A04AD10
EMBELINE 0.05% gel
Y
Rx
topical
D07AD01
EMBELINE 0.05% oint
Y
Rx
topical
D07AD01
EMBELINE 0.05% sol
Y
Rx
topical
D07AD01
EMBELINE E 0.05% cream
Y
Rx
topical
D07AD01
EPHEDRINE SULFATE 50MG/ML (50MG/ML) sol
Y
Rx
iv
C01CA26
EPINASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS
Y
Rx
ocular
S01GX10
EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) inj
Y
Rx
INJECTION
L01DB03
EPTIFIBATIDE 2MG/ML inj
Y
Rx
INJECTION
B01AC16
EPTIFIBATIDE 75MG/100ML inj
Y
Rx
INJECTION
B01AC16
ERYTHRO-STATIN 2% sol
N
topical
D10AF02
ERYTHROMYCIN 0.5% oint
Y
Rx
ocular
S01AA17
ERYTHROMYCIN 2% swab
Y
Rx
topical
D10AF02
ETHAMBUTOL HYDROCHLORIDE 100MG tabs
Y
Rx
oral
J04AK02
ETHAMBUTOL HYDROCHLORIDE 400MG tabs
Y
Rx
oral
J04AK02
ETHOSUXIMIDE 250MG caps
Y
Rx
oral
N03AD01
FAMOTIDINE 40MG/5ML FOR SUSPENSION
Y
Rx
oral
A02BA03
FLUOCINOLONE ACETONIDE 0.01% oil
Y
Rx
topical
D07AC04
FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS
Y
Rx
otic
S02BA08
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML sol
N
oral
N06AB03
FLUTICASONE PROPIONATE 0.05MG/SPRAY md spray
Y
Y
OTC
Rx
nasal
0
GABAPENTIN 250MG/5ML sol
Y
Rx
oral
N03AX12
GATIFLOXACIN 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01AE06
GENTAK EQ 0.3% BASE SOLUTION/DROPS
Y
Rx
ocular
S01AA11
GENTAMICIN SULFATE EQ 0.3% BASE oint
Y
Rx
ocular
S01AA11
GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS
Y
Rx
ocular
S01AA11
GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML inj
Y
Rx
INJECTION
A04AA02
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) inj
Y
Rx
INJECTION
A04AA02
GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) inj
Y
Rx
INJECTION
A04AA02
HALOPERIDOL EQ 5MG BASE/ML inj
Y
Rx
INJECTION
N05AD01
HEPARIN SODIUM 1,000 UNITS/ML inj
N
INJECTION
B01AB01
HEPARIN SODIUM 10,000 UNITS/ML inj
N
INJECTION
B01AB01
HEPARIN SODIUM 20,000 UNITS/ML inj
N
INJECTION
B01AB01
HEPARIN SODIUM 40,000 UNITS/ML inj
N
INJECTION
B01AB01
HEPARIN SODIUM 5,000 UNITS/ML inj
N
INJECTION
B01AB01
HYDASE 150 UNITS/ML inj
N
INJECTION
B06AA03
HYDRALAZINE HYDROCHLORIDE 20MG/ML inj
Y
Rx
INJECTION
C02DB02
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5 syrup
Y
Rx
oral
0
HYDROCORTISONE ACETATE 25MG/ML inj
N
INJECTION
0
HYDROCORTISONE ACETATE 50MG/ML inj
N
INJECTION
0
HYDROMORPHONE HYDROCHLORIDE 10MG/ML inj
Y
Y
Rx
Rx
INJECTION
N02AA03
HYDROXYPROGESTERONE CAPROATE 125MG/ML inj
N
INJECTION
G03DA03
HYDROXYZINE HYDROCHLORIDE 10MG/5ML syrup
Y
Rx
oral
N05BB01
IBUPROFEN 100MG/5ML susp
Y
Rx
oral
M01AE01
IC-GREEN inj
N
N
N


INJECTION
V04CX01
IC-GREEN 25MG/VIAL inj
Y
Rx
INJECTION
V04CX01
INAPSINE 2.5MG/ML inj
Y
Rx
INJECTION
N05AD08
INNOVAR 2.5MG/ML;EQ 0.05MG BASE/ML inj
N
INJECTION
N01AH51
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) inj
Y
Rx
INJECTION
L01XX19
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) inj
Y
Rx
INJECTION
L01XX19
KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS
Y
Rx
ocular
S01BC05
KETOROLAC TROMETHAMINE 0.45% SOLUTION/DROPS
N
ocular
S01BC05
KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01BC05
KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS
Y
OTC
ocular
S01GX08
LABETALOL HYDROCHLORIDE 5MG/ML inj
N
Y

Rx
INJECTION
C07AG01
LACTULOSE 10GM/15ML sol
Y
Y
Rx
Rx
oral
A06AD11
LATANOPROST 0.005% SOLUTION/DROPS
Y
Rx
ocular
S01EE01
LEVETIRACETAM 100MG/ML sol
Y
Rx
oral
N03AX14
LEVETIRACETAM 500MG/5ML (100MG/ML) inj
N
iv
N03AX14
LEVOCARNITINE 1GM/10ML sol
Y
Rx
oral
A16AA01
LEVOFLOXACIN 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01AE05
LEVOFLOXACIN 250MG/10ML sol
Y
Rx
oral
J01MA12
LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) inj
Y
Rx
INJECTION
J01MA12
LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) inj
Y
Rx
INJECTION
J01MA12
LIDOCAINE AND PRILOCAINE 2.5%;2.5% cream
Y
Rx
topical
0
LIDOCAINE HYDROCHLORIDE 1% inj
N
INJECTION
0
LIDOCAINE HYDROCHLORIDE 2% inj
N
INJECTION
0
LIDOCAINE HYDROCHLORIDE 2% jelly
Y
Rx
topical
0
LIDOCAINE HYDROCHLORIDE 2% sol
Y
Rx
oral
0
LOPERAMIDE HYDROCHLORIDE 1MG/5ML sol
Y
OTC
oral
A07DA03
LORAZEPAM 2MG/ML inj
Y
N
Rx
INJECTION
N05BA06
LORAZEPAM 2MG/ML conc
Y
Rx
oral
N05BA06
LOTEPREDNOL ETABONATE 0.5% drops, susp
Y
Rx
ocular
S01BA14
LOTEPREDNOL ETABONATE 0.5% gel
Y
Rx
ocular
S01BA14
MEGESTROL ACETATE 40MG/ML susp
Y
Rx
oral
L02AB01
METHADONE HYDROCHLORIDE 10MG/ML inj
Y
Rx
INJECTION
N07BC02
METHOTREXATE SODIUM 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML sol
N
IRRIGATION
V07AB
METHYLPREDNISOLONE ACETATE 40MG/ML inj
N
INJECTION
H02AB04
METHYLPREDNISOLONE ACETATE 80MG/ML inj
N
INJECTION
H02AB04
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML inj
Y
Rx
INJECTION
N05CD08
MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML syrup
Y
Rx
oral
N05CD08
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML inj
N
Y

Rx
INJECTION
N05CD08
MINOXIDIL (FOR MEN) 2% sol
Y
OTC
topical
D11AX01
MINOXIDIL (FOR WOMEN) 2% sol
Y
OTC
topical
D11AX01
MORPHINE SULFATE 100MG/5ML sol
Y
Rx
oral
N02AA01
MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01AE07
MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL inj
Y
Rx
INJECTION
L04AA06
NALOXONE HYDROCHLORIDE 0.4MG/ML inj
Y
Y
Rx
Rx
INJECTION
V03AB15
NANDROLONE DECANOATE 100MG/ML inj
N
INJECTION
A14AB01
NAPHAZOLINE HYDROCHLORIDE 0.1% SOLUTION/DROPS
N
ocular
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 0.025%;0.3 SOLUTION/DROPS
Y
OTC
ocular
S01GA51
NEDOCROMIL SODIUM 2% SOLUTION/DROPS
Y
Rx
ocular
S01GX04
NEMBUTAL 120MG supp
N
rectal
N05CA01
NEMBUTAL 18.2MG/5ML elixir
N
oral
N05CA01
NEMBUTAL 200MG supp
N
rectal
N05CA01
NEMBUTAL 30MG supp
N
rectal
N05CA01
NEMBUTAL 60MG supp
N
rectal
N05CA01
NEMBUTAL SODIUM 100MG caps
N
oral
N05CA01
NEMBUTAL SODIUM 30MG caps
N
oral
N05CA01
NEMBUTAL SODIUM 50MG caps
N
oral
N05CA01
NEMBUTAL SODIUM 50MG/ML inj
Y
Rx
INJECTION
N05CA01
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 400 UN oint
Y
Rx
ocular
S01AA30
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDRO oint
Y
Rx
ocular
S01CA03
NYSTATIN 100,000 UNITS/ML susp
Y
Rx
oral
A07AA02
NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% oint
Y
Rx
topical
D07CB01
OCUSERT PILO-20 5MG xr insert
N
ocular
S01EB01
OCUSERT PILO-40 11MG xr insert
N
ocular
S01EB01
OFLOXACIN 0.3% SOLUTION/DROPS
Y
Y
Y
Rx
Rx
Rx
ocular
S01AE01
OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY md spray
Y
Rx
nasal
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS
Y
Rx
ocular
S01GX09
OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS
Y
Rx
ocular
S01GX09
ORPHENADRINE CITRATE 30MG/ML inj
Y
Rx
INJECTION
M03BC01
OXYCODONE HYDROCHLORIDE 100MG/5ML sol
Y
Rx
oral
N02AA05
OXYCODONE HYDROCHLORIDE 5MG/5ML sol
Y
Rx
oral
N02AA05
PALONOSETRON HYDROCHLORIDE 0.25MG(BASE)/5ML inj
Y
INJECTION
A04AA05
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL inj
Y
Rx
iv
A02BC02
PAREMYD 1%;0.25% SOLUTION/DROPS
Y
Rx
ocular
X000053
PARICALCITOL 0.005MG/ML (0.005MG/ML) sol
Y
Rx
iv
H05BX02
PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS
Y
Rx
ocular
0
PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS
Y
Rx
ocular
0
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5 syrup
Y
Rx
oral
0
PILOCARPINE HYDROCHLORIDE 1% sol
Y
Rx
ocular
S01EB01
PILOCARPINE HYDROCHLORIDE 2% sol
Y
Rx
ocular
S01EB01
PILOCARPINE HYDROCHLORIDE 4% sol
Y
Rx
ocular
S01EB01
POTASSIUM CHLORIDE 2MEQ/ML inj
N
INJECTION
B05XA01
PREDAMIDE 0.5%;10% drops, susp
N
ocular
S01CA02
PREDNISOLONE 15MG/5ML syrup
Y
Rx
oral
0
PREDNISOLONE ACETATE 25MG/ML inj
N
INJECTION
0
PREDNISOLONE ACETATE 50MG/ML inj
N
INJECTION
0
PREDNISOLONE SODIUM PHOSPHATE EQ 0.11% PHOSPHATE SOLUTION/DROPS
N
ocular
0
PREDNISOLONE SODIUM PHOSPHATE EQ 0.9% PHOSPHATE SOLUTION/DROPS
N
ocular
0
PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML sol
Y
Rx
oral
0
PROMETHAZINE HYDROCHLORIDE 25MG/ML inj
N
INJECTION
R06AD02
PROMETHAZINE HYDROCHLORIDE 50MG/ML inj
N
INJECTION
R06AD02
PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML syrup
Y
Rx
oral
R06AD02
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6. syrup
Y
Rx
oral
R06AD52
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup
N
oral
0
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CO syrup
Y
Rx
oral
R06AD52
PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01HA04
PYRAZINAMIDE 500MG tabs
Y
Rx
oral
J04AK01
PYRIDOXINE HYDROCHLORIDE 100MG/ML inj
N
INJECTION
A11HA02
RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML syrup
N
oral
A02BA02
RIFAMPIN 150MG caps
Y
Rx
oral
J04AB02
RIFAMPIN 300MG caps
Y
Rx
oral
J04AB02
RIFAMPIN 600MG/VIAL inj
Y
Rx
INJECTION
J04AB02
ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) sol
Y
Rx
INJECTION
N01BB09
ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) sol
Y
Rx
INJECTION
N01BB09
ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) sol
Y
Rx
INJECTION
N01BB09
SODIUM NITROPRUSSIDE 25MG/ML inj
Y
Rx
INJECTION
C02DD01
SODIUM SULFACETAMIDE 10% SOLUTION/DROPS
N
ocular
S01AB04
SODIUM SULFACETAMIDE 15% SOLUTION/DROPS
N
ocular
S01AB04
SODIUM SULFACETAMIDE 30% SOLUTION/DROPS
N
ocular
S01AB04
SUBLIMAZE PRESERVATIVE FREE EQ 0.05MG BASE/ML inj
Y
Rx
INJECTION
N01AH01
SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML inj
Y
Rx
INJECTION
N01AH03
SULFACETAMIDE SODIUM 10% SOLUTION/DROPS
Y
Rx
ocular
S01AB04
SULFACETAMIDE SODIUM 30% SOLUTION/DROPS
N
ocular
S01AB04
SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML susp
Y
Rx
oral
J01EE01
SULSTER EQ 0.23% PHOSPHATE;10% SOLUTION/DROPS
N
ocular
S01CA02
TERBUTALINE SULFATE 1MG/ML inj
Y
Rx
INJECTION
R03CC03
THIAMINE HYDROCHLORIDE 100MG/ML inj
N
INJECTION
A11DA01
THIORIDAZINE HYDROCHLORIDE 100MG/ML conc
N
oral
N05AC02
THIORIDAZINE HYDROCHLORIDE 30MG/ML conc
N
oral
N05AC02
TIMOLOL EQ 0.25% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED01
TIMOLOL EQ 0.5% BASE SOLUTION/DROPS
Y
Rx
ocular
S01ED01
TIMOLOL MALEATE 0.5% sol
Y
ocular
S01ED01
TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS
N
N

ocular
S01ED01
TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS
Y
Y
Y
Y
Rx
Rx
Rx
Rx
ocular
S01ED01
TOBRAMYCIN 300MG/5ML sol
Y
Rx
inh
J01GB01
TOBRAMYCIN SULFATE EQ 40MG BASE/ML inj
Y
Rx
INJECTION
J01GB01
TRANEXAMIC ACID 100MG/ML inj
Y
Y
Y
Rx
Rx
Rx
INJECTION
B02AA02
TRIAMCINOLONE ACETONIDE 0.025% lotion
Y
Rx
topical
D07AB09
TRIAMCINOLONE ACETONIDE 0.1% lotion
Y
Rx
topical
D07AB09
TRIAMCINOLONE ACETONIDE 0.1% paste
Y
Rx
dental
A01AC01
TRIAMCINOLONE ACETONIDE 0.147MG/GM spray
Y
Rx
topical
D07AB09
TRIAMCINOLONE DIACETATE 25MG/ML inj
N
INJECTION
H02AB08
TRIAMCINOLONE DIACETATE 40MG/ML inj
N
INJECTION
H02AB08
TRIFLURIDINE 1% SOLUTION/DROPS
Y
Rx
ocular
S01AD02
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML SOLUTION/DROPS
Y
Rx
ocular
S01AA30
TROPICACYL 0.5% SOLUTION/DROPS
Y
Rx
ocular
S01FA06
TROPICACYL 1% SOLUTION/DROPS
Y
Rx
ocular
S01FA06
TROPICAMIDE 1% SOLUTION/DROPS
N
ocular
S01FA06
VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE caps
Y
Rx
oral
A07AA09
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE caps
Y
Rx
oral
A07AA09
VORICONAZOLE 200MG tabs
Y
Rx
oral
J02AC03
VORICONAZOLE 50MG tabs
Y
Rx
oral
J02AC03
VOSOL 2% SOLUTION/DROPS
Y
Rx
otic
S02AA10
VOSOL HC 2%;1% SOLUTION/DROPS
Y
Rx
otic
S02CA03
XOPENEX EQ 0.0103% BASE sol
Y
Rx
inh
R03AC02
XOPENEX EQ 0.021% BASE sol
Y
Rx
inh
R03AC02
XOPENEX EQ 0.042% BASE sol
Y
Rx
inh
R03AC02
XOPENEX EQ 0.25% BASE sol
Y
Rx
inh
R03AC02
XYLOCAINE 2% jelly
N
topical
0
ZIOPTAN 0.0015% SOLUTION/DROPS
Y
Rx
ocular
S01EE05
ZOLEDRONIC ACID EQ 4MG BASE/5ML inj
Y
Rx
iv
M05BA08
ZOLEDRONIC ACID EQ 5MG BASE/100ML inj
Y
Rx
iv
M05BA08
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML sol
40119/1
ANDA
26-04-1996
ACETYLCYSTEINE 6GM/30ML (200MG/ML) inj
203173/1
ANDA
24-03-2015
ACYCLOVIR 200MG/5ML susp
77026/1
ANDA
07-06-2005
ADENOSINE 3MG/ML inj
78076/1
ANDA
31-10-2008
ADENOSINE 60MG/20ML (3MG/ML) sol
90450/1
ANDA
02-10-2014
ADENOSINE 90MG/30ML (3MG/ML) sol
90450/2
ANDA
02-10-2014
AK-FLUOR 10% EQ 500MG BASE/5ML (EQ 100MG BASE/ML) inj
22186/1
NDA
08-08-2008
AK-FLUOR 25% EQ 500MG BASE/2ML (EQ 250MG BASE/ML) inj
22186/2
NDA
08-08-2008
AK-PENTOLATE 1% SOLUTION/DROPS
85555/1
ANDA
01-01-1982
AKBETA 0.25% SOLUTION/DROPS
74779/1
ANDA
29-10-1996
AKBETA 0.5% SOLUTION/DROPS
74780/1
ANDA
29-10-1996
AKPENTOLATE 1% SOLUTION/DROPS
40164/1
ANDA
13-01-1997
AKPENTOLATE 2% SOLUTION/DROPS
40165/1
ANDA
13-01-1997
AKPRO 0.1% SOLUTION/DROPS
74382/1
ANDA
29-09-1995
AKTEN 3.5% gel
22221/1
NDA
07-10-2008
AKTOB 0.3% SOLUTION/DROPS
64096/1
ANDA
31-01-1996
ALBUTEROL SULFATE EQ 0.083% BASE sol
75063/1
ANDA
09-02-1999
ALBUTEROL SULFATE EQ 0.5% BASE sol
74543/1
ANDA
15-01-1998
ALBUTEROL SULFATE EQ 2MG BASE/5ML syrup
74749/1
ANDA
30-01-1998
ALFENTA EQ 0.5MG BASE/ML inj
19353/1
NDA
29-12-1986
AMANTADINE HYDROCHLORIDE 50MG/5ML syrup
74170/1
ANDA
28-10-1994
AMICAR inj
15229/2
NDA
01-01-1982
AMICAR 0.25GM/ML sol
15230/2
NDA
01-01-1982
AMICAR 1GM tabs
15197/2
NDA
24-06-2004
AMICAR 500MG tabs
15197/1
NDA
01-01-1982
AMINOCAPROIC 500MG tabs
75602/1
ANDA
24-05-2001
AMINOCAPROIC ACID 0.25GM/ML sol
74759/1
ANDA
02-09-1998
AMIODARONE HYDROCHLORIDE 50MG/ML inj
76232/1
ANDA
05-07-2006
APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS
77764/1
ANDA
12-03-2009
ATROPINE SULFATE 1% SOLUTION/DROPS
206289/1
NDA
18-07-2014
AZASITE 1% SOLUTION/DROPS
50810/1
NDA
27-04-2007
AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS
203660/1
ANDA
08-11-2016
AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY md spray
207610/1
ANDA
17-05-2019
AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY md spray
210032/1
ANDA
23-08-2019
BACITRACIN 50,000 UNITS/VIAL inj
206719/1
ANDA
20-10-2017
BACITRACIN ZINC AND POLYMYXIN B SULFATE 500 UNITS/GM;10,000 oint
64028/1
ANDA
30-01-1995
BAL 10% inj
5939/1
NDA
01-01-1982
BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML sol
75503/1
ANDA
27-09-2006
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE augmented lotion
208849/1
ANDA
11-10-2019
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE lotion
209896/1
ANDA
06-02-2018
BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS
75386/1
ANDA
30-06-2000
BETIMOL EQ 0.25% BASE SOLUTION/DROPS
20439/1
NDA
31-03-1995
BETIMOL EQ 0.5% BASE SOLUTION/DROPS
20439/2
NDA
31-03-1995
BIMATOPROST 0.03% SOLUTION/DROPS
203051/1
203299/1
ANDA
ANDA
09-10-2018
08-11-2018
BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS
76439/1
ANDA
14-03-2006
BROMFENAC SODIUM EQ 0.09% ACID SOLUTION/DROPS
203395/1
ANDA
22-01-2014
CALCIPOTRIENE 0.005% sol
77579/1
ANDA
19-11-2009
CALCITRIOL 0.001MG/ML inj
78066/1
ANDA
29-01-2008
CALCITRIOL 0.002MG/ML inj
78066/2
ANDA
29-01-2008
CAPASTAT SULFATE EQ 1GM BASE/VIAL inj
50095/1
NDA
01-01-1982
CARBOPLATIN 150MG/15ML (10MG/ML) inj
90475/2
ANDA
29-07-2009
CARBOPLATIN 450MG/45ML (10MG/ML) inj
90475/3
ANDA
29-07-2009
CARBOPLATIN 50MG/5ML (10MG/ML) inj
90475/1
ANDA
29-07-2009
CARBOPLATIN 600MG/60ML (10MG/ML) inj
91268/2
ANDA
28-07-2010
CEFTRIAXONE EQ 1GM BASE/VIAL inj
65305/3
ANDA
11-01-2008
CEFTRIAXONE EQ 250MG BASE/VIAL inj
65305/1
ANDA
11-01-2008
CEFTRIAXONE EQ 2GM BASE/VIAL inj
65305/4
ANDA
11-01-2008
CEFTRIAXONE EQ 500MG BASE/VIAL inj
65305/2
ANDA
11-01-2008
CHLORAMPHENICOL 0.5% SOLUTION/DROPS
62042/1
ANDA
01-01-1982
CHLORHEXIDINE GLUCONATE 0.12% sol
74356/1
ANDA
07-05-1996
CICLOPIROX 8% sol
78975/1
78270/1
ANDA
ANDA
17-02-2010
18-09-2007
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML sol
74664/1
ANDA
28-10-1997
CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS
76555/1
ANDA
11-12-2008
CLINDAMYCIN PHOSPHATE EQ 1% BASE swab
65513/1
ANDA
17-06-2010
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER EQ inj
203048/2
ANDA
04-04-2013
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER EQ inj
203048/3
ANDA
04-04-2013
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER EQ inj
203048/1
ANDA
04-04-2013
CLOBETASOL PROPIONATE 0.05% lotion
211348/1
ANDA
26-10-2018
CLOBETASOL PROPIONATE 0.05% shampoo
209871/1
ANDA
27-10-2017
CLOBETASOL PROPIONATE 0.05% spray
207218/1
ANDA
28-04-2017
COGENTIN 1MG/ML inj
12015/1
NDA
01-01-1982
COR-OTICIN 1.5%;EQ 3.5MG BASE/ML drops, susp
60188/1
ANDA
01-01-1982
CORMAX 0.05% cream
74220/1
ANDA
16-05-1997
COSOPT EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS
20869/1
NDA
07-04-1998
COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS
202667/1
NDA
01-02-2012
CROMOLYN SODIUM 4% SOLUTION/DROPS
74706/1
ANDA
29-04-1998
CYANOCOBALAMIN 1MG/ML inj
87969/1
ANDA
10-11-1983
CYCLOPENTOLATE HYDROCHLORIDE 0.5% SOLUTION/DROPS
205937/1
ANDA
09-12-2015
DEMECLOCYCLINE HYDROCHLORIDE 150MG tabs
65389/1
ANDA
01-12-2008
DEMECLOCYCLINE HYDROCHLORIDE 300MG tabs
65389/2
ANDA
01-12-2008
DESONIDE 0.05% oint
208836/1
ANDA
27-03-2017
DESOXIMETASONE 0.05% gel
90727/1
ANDA
10-03-2011
DESOXIMETASONE 0.05% cream
203787/1
ANDA
06-01-2017
DESOXIMETASONE 0.25% oint
201005/1
ANDA
24-04-2014
DESOXIMETASONE 0.25% cream
203234/1
ANDA
12-06-2015
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE SOLUTION/DROPS
84855/1
ANDA
01-01-1982
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML inj
84493/1
ANDA
01-01-1982
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG inj
202585/1
ANDA
24-11-2014
DICLOFENAC SODIUM 0.1% SOLUTION/DROPS
77845/1
ANDA
17-04-2008
DICLOFENAC SODIUM 1.5% sol
206655/1
ANDA
28-01-2021
DICLOFENAC SODIUM 1% gel
209484/1
ANDA
21-11-2018
DICYCLOMINE HYDROCHLORIDE 10MG/ML inj
207084/1
ANDA
04-05-2018
DIFLORASONE DIACETATE 0.05% oint
206572/1
ANDA
24-07-2015
DILTIAZEM HYDROCHLORIDE 5MG/ML inj
75086/1
ANDA
09-04-1998
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML syrup
72416/1
ANDA
28-09-1990
DIURIL tabs
11145/4
11145/2
NDA
NDA
01-01-1982
01-01-1982
DIURIL EQ 500MG BASE/VIAL inj
11145/5
NDA
01-01-1982
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE EQ 2% BASE;EQ SOLUTION/DROPS
77847/1
203058/1
ANDA
ANDA
28-10-2008
22-09-2014
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS
77846/1
ANDA
28-10-2008
DOXERCALCIFEROL 2MCG/ML (2MCG/ML) inj
203929/2
ANDA
28-03-2016
DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) inj
203929/1
ANDA
07-05-2015
DRONABINOL 10MG caps
79217/3
ANDA
20-06-2014
DRONABINOL 2.5MG caps
79217/1
ANDA
20-06-2014
DRONABINOL 5MG caps
79217/2
ANDA
20-06-2014
EMBELINE 0.05% gel
76141/1
ANDA
12-04-2002
EMBELINE 0.05% oint
74221/1
ANDA
31-03-1995
EMBELINE 0.05% sol
74222/1
ANDA
06-12-1995
EMBELINE E 0.05% cream
75325/1
ANDA
24-12-1998
EPHEDRINE SULFATE 50MG/ML (50MG/ML) sol
208609/1
NDA
01-03-2017
EPINASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS
204055/1
ANDA
05-05-2017
EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) inj
90163/1
ANDA
24-06-2009
EPTIFIBATIDE 2MG/ML inj
204589/1
ANDA
18-04-2017
EPTIFIBATIDE 75MG/100ML inj
204589/2
ANDA
18-04-2017
ERYTHRO-STATIN 2% sol
64101/1
ANDA
22-10-1996
ERYTHROMYCIN 0.5% oint
64030/1
ANDA
18-07-1996
ERYTHROMYCIN 2% swab
90215/1
ANDA
12-05-2010
ETHAMBUTOL HYDROCHLORIDE 100MG tabs
75095/1
ANDA
30-11-1999
ETHAMBUTOL HYDROCHLORIDE 400MG tabs
75095/2
ANDA
30-11-1999
ETHOSUXIMIDE 250MG caps
40686/1
ANDA
28-05-2008
FAMOTIDINE 40MG/5ML FOR SUSPENSION
201995/1
ANDA
30-05-2014
FLUOCINOLONE ACETONIDE 0.01% oil
91514/1
ANDA
25-06-2015
FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS
202705/1
ANDA
09-09-2016
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML sol
75525/1
ANDA
27-06-2002
FLUTICASONE PROPIONATE 0.05MG/SPRAY md spray
77570/1
208024/1
ANDA
ANDA
16-01-2008
17-04-2019
GABAPENTIN 250MG/5ML sol
78974/1
ANDA
18-02-2011
GATIFLOXACIN 0.5% SOLUTION/DROPS
203189/1
ANDA
03-09-2014
GENTAK EQ 0.3% BASE SOLUTION/DROPS
64163/1
ANDA
12-10-2001
GENTAMICIN SULFATE EQ 0.3% BASE oint
64093/1
ANDA
31-08-1995
GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS
62635/1
ANDA
08-01-1987
GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML inj
79119/1
ANDA
10-09-2009
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) inj
79078/1
ANDA
14-09-2009
GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) inj
79078/2
ANDA
14-09-2009
HALOPERIDOL EQ 5MG BASE/ML inj
204849/1
ANDA
06-09-2017
HEPARIN SODIUM 1,000 UNITS/ML inj
17486/1
NDA
01-01-1982
HEPARIN SODIUM 10,000 UNITS/ML inj
17486/3
NDA
01-01-1982
HEPARIN SODIUM 20,000 UNITS/ML inj
17486/4
NDA
01-01-1982
HEPARIN SODIUM 40,000 UNITS/ML inj
17486/5
NDA
01-01-1982
HEPARIN SODIUM 5,000 UNITS/ML inj
17486/2
NDA
01-01-1982
HYDASE 150 UNITS/ML inj
21716/1
BLA
HYDRALAZINE HYDROCHLORIDE 20MG/ML inj
40730/1
ANDA
21-04-2009
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5 syrup
40613/1
ANDA
08-02-2008
HYDROCORTISONE ACETATE 25MG/ML inj
9637/1
NDA
01-01-1982
HYDROCORTISONE ACETATE 50MG/ML inj
9637/2
NDA
01-01-1982
HYDROMORPHONE HYDROCHLORIDE 10MG/ML inj
78228/1
78261/1
ANDA
ANDA
14-04-2010
14-04-2010
HYDROXYPROGESTERONE CAPROATE 125MG/ML inj
18004/1
NDA
01-01-1982
HYDROXYZINE HYDROCHLORIDE 10MG/5ML syrup
40010/1
ANDA
28-10-1994
IBUPROFEN 100MG/5ML susp
205647/1
ANDA
03-11-2016
IC-GREEN inj
11525/4
11525/3
11525/2
NDA
NDA
NDA
01-01-1982
01-01-1982
01-01-1982
IC-GREEN 25MG/VIAL inj
11525/1
NDA
01-01-1982
INAPSINE 2.5MG/ML inj
16796/1
NDA
01-01-1982
INNOVAR 2.5MG/ML;EQ 0.05MG BASE/ML inj
16049/1
NDA
01-01-1982
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) inj
90726/2
ANDA
16-09-2009
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) inj
90726/1
ANDA
16-09-2009
KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS
78399/1
ANDA
05-11-2009
KETOROLAC TROMETHAMINE 0.45% SOLUTION/DROPS
203376/1
ANDA
10-02-2014
KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS
78434/1
ANDA
05-11-2009
KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS
77958/1
ANDA
26-07-2007
LABETALOL HYDROCHLORIDE 5MG/ML inj
75524/1
75431/1
ANDA
ANDA
29-11-1999
29-11-1999
LACTULOSE 10GM/15ML sol
74076/1
74077/1
ANDA
ANDA
03-07-1995
03-07-1995
LATANOPROST 0.005% SOLUTION/DROPS
90887/1
ANDA
19-07-2011
LEVETIRACETAM 100MG/ML sol
90601/1
ANDA
28-02-2012
LEVETIRACETAM 500MG/5ML (100MG/ML) inj
209934/1
ANDA
04-05-2018
LEVOCARNITINE 1GM/10ML sol
77399/1
ANDA
25-10-2007
LEVOFLOXACIN 0.5% SOLUTION/DROPS
90268/1
ANDA
20-12-2010
LEVOFLOXACIN 250MG/10ML sol
91678/1
ANDA
20-06-2011
LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) inj
91644/1
ANDA
20-06-2011
LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) inj
91644/2
ANDA
20-06-2011
LIDOCAINE AND PRILOCAINE 2.5%;2.5% cream
76290/1
ANDA
25-09-2003
LIDOCAINE HYDROCHLORIDE 1% inj
85037/1
ANDA
01-01-1982
LIDOCAINE HYDROCHLORIDE 2% inj
85037/2
ANDA
01-01-1982
LIDOCAINE HYDROCHLORIDE 2% jelly
40433/1
ANDA
12-02-2003
LIDOCAINE HYDROCHLORIDE 2% sol
40014/1
ANDA
10-07-1995
LOPERAMIDE HYDROCHLORIDE 1MG/5ML sol
74352/1
ANDA
17-11-1995
LORAZEPAM 2MG/ML inj
74974/1
75025/1
ANDA
ANDA
23-07-1998
23-07-1998
LORAZEPAM 2MG/ML conc
200169/1
ANDA
30-01-2012
LOTEPREDNOL ETABONATE 0.5% drops, susp
207609/1
ANDA
17-04-2019
LOTEPREDNOL ETABONATE 0.5% gel
212080/1
ANDA
10-02-2021
MEGESTROL ACETATE 40MG/ML susp
203960/1
ANDA
09-06-2017
METHADONE HYDROCHLORIDE 10MG/ML inj
208306/1
ANDA
27-10-2017
METHOTREXATE SODIUM 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML sol
20079/1
NDA
26-02-1999
METHYLPREDNISOLONE ACETATE 40MG/ML inj
86903/1
ANDA
20-10-1982
METHYLPREDNISOLONE ACETATE 80MG/ML inj
86903/2
ANDA
20-10-1982
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML inj
75494/1
ANDA
30-06-2000
MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML syrup
75958/1
ANDA
04-09-2003
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML inj
75494/2
75481/1
ANDA
ANDA
30-06-2000
30-06-2000
MINOXIDIL (FOR MEN) 2% sol
74731/1
ANDA
24-12-1996
MINOXIDIL (FOR WOMEN) 2% sol
74731/2
ANDA
11-05-2005
MORPHINE SULFATE 100MG/5ML sol
208809/1
ANDA
06-07-2017
MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS
202916/1
ANDA
09-11-2017
MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL inj
204043/1
ANDA
28-02-2017
NALOXONE HYDROCHLORIDE 0.4MG/ML inj
208872/1
208871/1
ANDA
ANDA
14-03-2017
28-02-2017
NANDROLONE DECANOATE 100MG/ML inj
87519/1
ANDA
28-09-1983
NAPHAZOLINE HYDROCHLORIDE 0.1% SOLUTION/DROPS
83590/1
ANDA
01-01-1982
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 0.025%;0.3 SOLUTION/DROPS
202795/1
ANDA
24-01-2013
NEDOCROMIL SODIUM 2% SOLUTION/DROPS
90638/1
ANDA
22-08-2012
NEMBUTAL 120MG supp
83247/3
ANDA
25-01-1982
NEMBUTAL 18.2MG/5ML elixir
83244/1
ANDA
01-01-1982
NEMBUTAL 200MG supp
83247/4
ANDA
25-01-1982
NEMBUTAL 30MG supp
83247/1
ANDA
25-01-1982
NEMBUTAL 60MG supp
83247/2
ANDA
25-01-1982
NEMBUTAL SODIUM 100MG caps
83245/1
ANDA
01-01-1982
NEMBUTAL SODIUM 30MG caps
84095/1
ANDA
01-01-1982
NEMBUTAL SODIUM 50MG caps
84093/1
ANDA
01-01-1982
NEMBUTAL SODIUM 50MG/ML inj
83246/1
ANDA
01-01-1982
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 400 UN oint
65088/1
ANDA
06-02-2004
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDRO oint
65213/1
ANDA
25-07-2012
NYSTATIN 100,000 UNITS/ML susp
64042/1
ANDA
28-02-1994
NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% oint
207217/1
ANDA
04-08-2017
OCUSERT PILO-20 5MG xr insert
17431/1
NDA
01-01-1982
OCUSERT PILO-40 11MG xr insert
17548/1
NDA
01-01-1982
OFLOXACIN 0.3% SOLUTION/DROPS
76407/1
76616/1
76615/1
ANDA
ANDA
ANDA
15-04-2008
17-03-2008
14-05-2004
OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY md spray
213757/1
ANDA
19-08-2020
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS
204532/1
ANDA
10-01-2017
OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS
204723/1
ANDA
05-12-2017
ORPHENADRINE CITRATE 30MG/ML inj
40484/1
ANDA
24-05-2006
OXYCODONE HYDROCHLORIDE 100MG/5ML sol
208795/1
ANDA
07-08-2017
OXYCODONE HYDROCHLORIDE 5MG/5ML sol
208817/1
ANDA
10-08-2017
PALONOSETRON HYDROCHLORIDE 0.25MG(BASE)/5ML inj
204731/1
ANDA
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL inj
79197/1
ANDA
08-11-2012
PAREMYD 1%;0.25% SOLUTION/DROPS
19261/1
NDA
30-01-1992
PARICALCITOL 0.005MG/ML (0.005MG/ML) sol
207692/1
ANDA
16-10-2017
PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS
207926/2
NDA
15-01-2015
PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS
207926/1
NDA
15-01-2015
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5 syrup
40675/1
ANDA
23-12-2014
PILOCARPINE HYDROCHLORIDE 1% sol
204398/1
ANDA
27-09-2017
PILOCARPINE HYDROCHLORIDE 2% sol
204398/2
ANDA
27-09-2017
PILOCARPINE HYDROCHLORIDE 4% sol
204398/3
ANDA
27-09-2017
POTASSIUM CHLORIDE 2MEQ/ML inj
88286/1
ANDA
05-09-1985
PREDAMIDE 0.5%;10% drops, susp
88059/1
ANDA
29-07-1983
PREDNISOLONE 15MG/5ML syrup
40401/1
ANDA
27-02-2003
PREDNISOLONE ACETATE 25MG/ML inj
83032/1
ANDA
01-01-1982
PREDNISOLONE ACETATE 50MG/ML inj
84492/1
ANDA
01-01-1982
PREDNISOLONE SODIUM PHOSPHATE EQ 0.11% PHOSPHATE SOLUTION/DROPS
83358/1
ANDA
01-01-1982
PREDNISOLONE SODIUM PHOSPHATE EQ 0.9% PHOSPHATE SOLUTION/DROPS
83358/2
ANDA
01-01-1982
PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML sol
75183/1
ANDA
26-03-2003
PROMETHAZINE HYDROCHLORIDE 25MG/ML inj
83955/2
ANDA
01-01-1982
PROMETHAZINE HYDROCHLORIDE 50MG/ML inj
83955/1
ANDA
01-01-1982
PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML syrup
40026/1
ANDA
25-09-1998
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6. syrup
40151/1
ANDA
26-08-1997
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup
40027/1
ANDA
31-07-1996
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CO syrup
40674/1
ANDA
23-12-2014
PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS
40277/1
ANDA
16-03-2000
PYRAZINAMIDE 500MG tabs
81319/1
ANDA
30-06-1992
PYRIDOXINE HYDROCHLORIDE 100MG/ML inj
87967/1
ANDA
01-10-1982
RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML syrup
91078/1
ANDA
22-03-2011
RIFAMPIN 150MG caps
65028/1
ANDA
14-03-2001
RIFAMPIN 300MG caps
65028/2
ANDA
14-03-2001
RIFAMPIN 600MG/VIAL inj
65502/1
ANDA
21-09-2010
ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) sol
203955/1
ANDA
11-04-2016
ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) sol
204636/1
ANDA
16-03-2018
ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) sol
204636/2
ANDA
16-03-2018
SODIUM NITROPRUSSIDE 25MG/ML inj
208635/1
ANDA
04-05-2017
SODIUM SULFACETAMIDE 10% SOLUTION/DROPS
83021/1
ANDA
01-01-1982
SODIUM SULFACETAMIDE 15% SOLUTION/DROPS
83021/2
ANDA
01-01-1982
SODIUM SULFACETAMIDE 30% SOLUTION/DROPS
83021/3
ANDA
01-01-1982
SUBLIMAZE PRESERVATIVE FREE EQ 0.05MG BASE/ML inj
16619/1
NDA
01-01-1982
SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML inj
19050/1
NDA
04-05-1984
SULFACETAMIDE SODIUM 10% SOLUTION/DROPS
40215/1
ANDA
25-05-1999
SULFACETAMIDE SODIUM 30% SOLUTION/DROPS
40216/1
ANDA
25-05-1999
SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML susp
74650/1
ANDA
29-12-1997
SULSTER EQ 0.23% PHOSPHATE;10% SOLUTION/DROPS
74511/1
ANDA
30-07-1996
TERBUTALINE SULFATE 1MG/ML inj
78151/1
ANDA
07-01-2008
THIAMINE HYDROCHLORIDE 100MG/ML inj
87968/1
ANDA
01-10-1982
THIORIDAZINE HYDROCHLORIDE 100MG/ML conc
40126/1
ANDA
16-08-1996
THIORIDAZINE HYDROCHLORIDE 30MG/ML conc
40125/1
ANDA
16-08-1996
TIMOLOL EQ 0.25% BASE SOLUTION/DROPS
205309/1
ANDA
30-09-2016
TIMOLOL EQ 0.5% BASE SOLUTION/DROPS
205309/2
ANDA
30-09-2016
TIMOLOL MALEATE 0.5% sol
204912/1
ANDA
TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS
74515/1
74465/1
ANDA
ANDA
25-03-1997
25-03-1997
TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS
75163/1
74516/1
212291/1
74466/1
ANDA
ANDA
ANDA
ANDA
10-09-2002
25-03-1997
11-09-2020
25-03-1997
TOBRAMYCIN 300MG/5ML sol
201422/1
ANDA
28-05-2014
TOBRAMYCIN SULFATE EQ 40MG BASE/ML inj
205179/1
ANDA
16-09-2014
TRANEXAMIC ACID 100MG/ML inj
206634/1
206594/1
202373/1
ANDA
ANDA
ANDA
09-06-2016
28-09-2017
17-11-2011
TRIAMCINOLONE ACETONIDE 0.025% lotion
202374/1
ANDA
08-05-2013
TRIAMCINOLONE ACETONIDE 0.1% lotion
202374/2
ANDA
08-05-2013
TRIAMCINOLONE ACETONIDE 0.1% paste
206312/1
ANDA
11-08-2016
TRIAMCINOLONE ACETONIDE 0.147MG/GM spray
207094/1
ANDA
07-12-2016
TRIAMCINOLONE DIACETATE 25MG/ML inj
85122/1
ANDA
01-01-1982
TRIAMCINOLONE DIACETATE 40MG/ML inj
86394/1
ANDA
01-01-1982
TRIFLURIDINE 1% SOLUTION/DROPS
205438/1
ANDA
28-07-2017
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML SOLUTION/DROPS
65006/1
ANDA
17-12-1998
TROPICACYL 0.5% SOLUTION/DROPS
40314/1
ANDA
29-09-2000
TROPICACYL 1% SOLUTION/DROPS
40315/1
ANDA
29-09-2000
TROPICAMIDE 1% SOLUTION/DROPS
88447/1
ANDA
28-08-1985
VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE caps
65478/1
ANDA
09-04-2012
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE caps
65478/2
ANDA
09-04-2012
VORICONAZOLE 200MG tabs
207049/2
ANDA
07-09-2016
VORICONAZOLE 50MG tabs
207049/1
ANDA
07-09-2016
VOSOL 2% SOLUTION/DROPS
12179/1
NDA
01-01-1982
VOSOL HC 2%;1% SOLUTION/DROPS
12770/1
NDA
01-01-1982
XOPENEX EQ 0.0103% BASE sol
20837/3
NDA
30-01-2002
XOPENEX EQ 0.021% BASE sol
20837/1
NDA
25-03-1999
XOPENEX EQ 0.042% BASE sol
20837/2
NDA
25-03-1999
XOPENEX EQ 0.25% BASE sol
20837/4
NDA
18-07-2003
XYLOCAINE 2% jelly
8816/1
NDA
01-01-1982
ZIOPTAN 0.0015% SOLUTION/DROPS
202514/1
NDA
10-02-2012
ZOLEDRONIC ACID EQ 4MG BASE/5ML inj
202548/1
ANDA
22-05-2014
ZOLEDRONIC ACID EQ 5MG BASE/100ML inj
200918/1
ANDA
21-08-2014
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Europe

Austria (0)
No result.
Belgium (0)
No result.
Bosnia and Herzegovina (0)
No result.
Croatia (0)
No result.
Czechia (0)
No result.
Denmark (0)
No result.
Finland (0)
No result.
Hungary (0)
No result.
Iceland (0)
No result.
Ireland (0)
No result.
Lithuania (0)
No result.
Malta (0)
No result.
Netherlands (0)
No result.
Norway (2)
X
Product
Pack
Market
Pres.
Dosage
ATC
API
FUL-GLO 1 MG Øyestrip
100
-
Rx
ocular
S01JA01
SODIUM CHLORIDE AKORN ØYESALVE 5 % W/W eye oint
3.5
-
Rx
ocular
S01XA03
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
FUL-GLO 1 MG Øyestrip
100
01-01-2014
SODIUM CHLORIDE AKORN ØYESALVE 5 % W/W eye oint
3.5
15-12-2020
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Poland (0)
No result.
Romania (0)
No result.
Slovenia (0)
No result.
Spain (0)
No result.
Sweden (0)
No result.
Switzerland (0)
No result.