← FDA DRUG APPROVALS

FDA NDA · NDA018841

DAYPRO

Sponsor: PFIZER

APPLICATION
NDA018841
TYPE
NDA
ORIGINAL APPROVAL
1992-10-29
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DAYPRO · ReferenceDiscontinued
OXAPROZIN 600MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 36 · standard — Letter ↗AP
2022-11-09Labeling · Supplement 34 · standard — Label ↗AP
2021-04-28Labeling · Supplement 33 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 30 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 28 · standard — Letter ↗AP
2007-06-21Labeling · Supplement 22 · standard — Label ↗AP
2006-01-18Labeling · Supplement 21 · standard — Letter ↗AP
2003-04-10Labeling · Supplement 20 · standard — Letter ↗AP
2002-01-25Efficacy · Supplement 16 · standard — Label ↗AP
2002-01-25Labeling · Supplement 12 · standard — Letter ↗AP
2000-09-08Manufacturing (CMC) · Supplement 18 · standardAP
2000-02-22Manufacturing (CMC) · Supplement 17 · standardAP
1998-01-06Labeling · Supplement 9 · standardAP
1998-01-06Labeling · Supplement 7 · standardAP
1998-01-06Labeling · Supplement 14 · standardAP
1998-01-06Labeling · Supplement 15 · standardAP
1997-05-08Manufacturing (CMC) · Supplement 11 · standardAP
1996-09-10Manufacturing (CMC) · Supplement 6 · standardAP
1996-06-13Manufacturing (CMC) · Supplement 8 · standardAP
1996-06-11Manufacturing (CMC) · Supplement 10 · standardAP
1995-11-03Manufacturing (CMC) · Supplement 3 · standardAP
1995-04-06Labeling · Supplement 5 · standardAP
1995-02-22Labeling · Supplement 4 · standardAP
1993-12-27Labeling · Supplement 2 · standardAP
1993-04-02Labeling · Supplement 1 · standardAP
1992-10-29Type 1 - New Molecular Entity · Original · standardAP
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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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