Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204812
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/2015 ORIG-1 Approval

Label is not available on this site.

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.1% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204532 AKORN INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209919 ALEMBIC PHARMS LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078350 APOTEX
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204812 AUROBINDO PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206046 CIPLA
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209282 FDC LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209619 GLAND PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204392 MYLAN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206306 SOMERSET THERAPS LLC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203152 USV
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 200810 WOCKHARDT LTD
PATANOL OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020688 NOVARTIS

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