← FDA DRUG APPROVALS

FDA NDA · NDA020688

PATADAY TWICE A DAY RELIEF

olopatadine hydrochloride

Sponsor: ALCON LABS INC

APPLICATION
NDA020688
TYPE
NDA
ORIGINAL APPROVAL
1996-12-18
LATEST ACTION
2025-04-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

PATADAY TWICE DAILY RELIEF · ReferenceOver-the-counter
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-04-15Labeling · Supplement 37 · standard — Letter ↗AP
2020-09-30Labeling · Supplement 33 · standard — Letter ↗AP
2020-02-14Efficacy · Supplement 32 · standard — Letter ↗AP
2015-06-30Manufacturing (CMC) · Supplement 28 · standardAP
2013-09-12Manufacturing (CMC) · Supplement 25 · standardAP
2003-04-17Labeling · Supplement 16 · standard — Label ↗AP
2002-03-13Manufacturing (CMC) · Supplement 15 · standardAP
2001-08-24Manufacturing (CMC) · Supplement 14 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 13 · standard — Review ↗AP
2000-03-20Efficacy · Supplement 12 · priority — Letter ↗AP
2000-02-18Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
1999-09-28Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
1999-08-19Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1999-08-17Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
1999-03-11Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1999-02-16Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
1999-02-05Manufacturing (CMC) · Supplement 7 · standardAP
1998-10-14Manufacturing (CMC) · Supplement 5 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1998-05-29Labeling · Supplement 3 · standard — Review ↗AP
1998-01-15Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1996-12-18Type 1 - New Molecular Entity · Original · standard — Review ↗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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