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FDA NDA · NDA020607

DICLOFENAC SODIUM AND MISOPROSTOL

Sponsor: PFIZER

APPLICATION
NDA020607
TYPE
NDA
ORIGINAL APPROVAL
1997-12-24
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ARTHROTEC · ReferencePrescription
DICLOFENAC SODIUM 75MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL
ARTHROTEC · ReferencePrescription
DICLOFENAC SODIUM 50MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 43 · standard — Letter ↗AP
2022-12-22Labeling · Supplement 41 · standard — Letter ↗AP
2022-08-26Labeling · Supplement 40 · standard — Letter ↗AP
2021-08-02Labeling · Supplement 39 · standard — Label ↗AP
2021-04-28Labeling · Supplement 38 · standard — Letter ↗AP
2020-09-24Labeling · Supplement 36 · standard — Letter ↗AP
2020-07-28Labeling · Supplement 33 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 31 · standard — Label ↗AP
2015-04-01Labeling · Supplement 21 · standard — Letter ↗AP
2014-09-03Labeling · Supplement 28 · standard — Label ↗AP
2013-03-07Labeling · Supplement 25 · standard — Label ↗AP
2013-02-08Manufacturing (CMC) · Supplement 26 · standardAP
2010-12-21Labeling · Supplement 16 · unknown — Letter ↗AP
2009-09-11Labeling · Supplement 13 · standard — Label ↗AP
2009-02-25Labeling · Supplement 14 · 901 required — Letter ↗AP
2007-08-24Labeling · Supplement 10 · standard — Label ↗AP
2006-01-25Labeling · Supplement 9 · standard — Label ↗AP
2005-07-08Labeling · Supplement 8 · standard — Letter ↗AP
2002-05-20Manufacturing (CMC) · Supplement 7 · standardAP
2000-10-03Labeling · Supplement 5 · standardAP
1999-02-22Labeling · Supplement 4 · standard — Review ↗AP
1998-07-20Manufacturing (CMC) · Supplement 3 · standardAP
1998-04-15Manufacturing (CMC) · Supplement 1 · standardAP
1998-03-16Manufacturing (CMC) · Supplement 2 · standardAP
1997-12-24Type 4 - New Combination · 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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