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FDA NDA · NDA206276

PATADAY ONCE DAILY RELIEF

olopatadine hydrochloride

Sponsor: ALCON LABS INC

APPLICATION
NDA206276
TYPE
NDA
ORIGINAL APPROVAL
2015-01-30
LATEST ACTION
2025-04-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

PATADAY ONCE DAILY RELIEF · ReferenceOver-the-counter
OLOPATADINE HYDROCHLORIDE EQ 0.7% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-04-15Labeling · Supplement 11 · standard — Letter ↗AP
2021-10-25Manufacturing (CMC) · Supplement 6 — Label ↗AP
2020-07-13Efficacy · Supplement 5 · standard — Letter ↗AP
2015-11-27Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
2015-01-30Type 5 - New Formulation or New Manufacturer · Original · priority — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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