Drugs@FDA: FDA-Approved Drugs

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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 Over-the-counter None 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.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2020 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

OLOPATADINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/DROPS;OPHTHALMIC; EQ 0.1% BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 078350 APOTEX
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 204812 AUROBINDO PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209619 GLAND PHARMA LTD
PATADAY TWICE DAILY RELIEF OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 020688 ALCON LABS INC

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