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FDA ANDA · ANDA206046

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA206046
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-26
LATEST ACTION
2024-08-07
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

2024-08-07Manufacturing (CMC) · Supplement 3 · unknownAP
2020-12-18Labeling · Supplement 2 · standardAP
2017-07-26UNKNOWN · Original · standardAP
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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