← FDA DRUG APPROVALS

FDA NDA · NDA018147

FELDENE

Sponsor: PFIZER

APPLICATION
NDA018147
TYPE
NDA
ORIGINAL APPROVAL
1982-04-06
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FELDENE · ReferencePrescription
PIROXICAM 10MG · CAPSULE · ORAL
FELDENE · ReferencePrescription
PIROXICAM 20MG · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 53 · standard — Letter ↗AP
2022-11-09Labeling · Supplement 52 · standard — Label ↗AP
2021-04-28Labeling · Supplement 50 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 48 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 44 · standard — Letter ↗AP
2015-02-27Labeling · Supplement 33 · unknown — Label ↗AP
2015-02-27Labeling · Supplement 38 · standard — Letter ↗AP
2015-02-27Labeling · Supplement 42 · standard — Letter ↗AP
2015-02-27Labeling · Supplement 40 · standard — Letter ↗AP
2015-02-27Labeling · Supplement 39 · standard — Letter ↗AP
2013-06-19Manufacturing (CMC) · Supplement 41 · standardAP
2010-08-13Labeling · Supplement 32 · unknown — Letter ↗AP
2007-07-05Labeling · Supplement 30 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 29 · standard — Label ↗AP
2003-01-08Labeling · Supplement 28 · standard — Letter ↗AP
2000-03-09Manufacturing (CMC) · Supplement 27 · standardAP
1998-05-14Labeling · Supplement 23AP
1998-05-14Labeling · Supplement 21AP
1998-05-14Labeling · Supplement 26 · standardAP
1998-05-14Labeling · Supplement 18AP
1994-05-25Manufacturing (CMC) · Supplement 24 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 25 · standardAP
1989-05-16Manufacturing (CMC) · Supplement 22 · standardAP
1988-08-24Labeling · Supplement 20AP
1987-07-23Manufacturing (CMC) · Supplement 19 · standardAP
1986-04-23Manufacturing (CMC) · Supplement 16 · standardAP
1985-09-18Labeling · Supplement 15AP
1984-12-10Labeling · Supplement 12AP
1984-11-19Labeling · Supplement 11AP
1984-09-17Manufacturing (CMC) · Supplement 8 · standardAP
1984-09-10Manufacturing (CMC) · Supplement 9 · standardAP
1984-07-17Labeling · Supplement 10AP
1984-05-03Manufacturing (CMC) · Supplement 6 · standardAP
1983-10-21Labeling · Supplement 7AP
1983-03-18Labeling · Supplement 4AP
1983-02-22Labeling · Supplement 3AP
1983-01-13Manufacturing (CMC) · Supplement 2 · standardAP
1982-04-06Type 1 - New Molecular Entity · Original · standardAP
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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