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FDA ANDA · ANDA200810

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride ophthalmic

Sponsor: GLENMARK PHARMS

APPLICATION
ANDA200810
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-28
LATEST ACTION
2021-08-26
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

OLOPATADINE HYDROCHLORIDEOver-the-counter
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-08-26Labeling · Supplement 1 · standardAP
2017-06-28Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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