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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209919
Company: ALEMBIC PHARMS 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
12/07/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2021 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

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 204532 AKORN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209919 ALEMBIC PHARMS LTD
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 EUGIA PHARMA
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209619 GLAND PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 203152 USV
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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