← FDA DRUG APPROVALS

FDA NDA · NDA021545

PATADAY ONCE DAILY RELIEF

olopatadine hydrochloride

Sponsor: ALCON LABS INC

APPLICATION
NDA021545
TYPE
NDA
ORIGINAL APPROVAL
2004-12-22
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 0.2% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-04-15Labeling · Supplement 29 · standard — Letter ↗AP
2021-05-13Labeling · Supplement 24 · standard — Label ↗AP
2020-09-30Labeling · Supplement 23 · standard — Letter ↗AP
2020-02-14Efficacy · Supplement 22 · standard — Letter ↗AP
2015-10-08Manufacturing (CMC) · Supplement 18 · standardAP
2010-12-08Labeling · Supplement 13 · standard — Label ↗AP
2007-06-08Labeling · Supplement 8 · standard — Letter ↗AP
2007-06-08Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2007-04-26Labeling · Supplement 6 · standard — Label ↗AP
2006-10-04Labeling · Supplement 4 · standardAP
2004-12-22Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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