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FDA NDA · NDA019322

TEMOVATE

Sponsor: FOUGERA PHARMS

APPLICATION
NDA019322
TYPE
NDA
ORIGINAL APPROVAL
1985-12-27
LATEST ACTION
2003-04-02
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

TEMOVATE · ReferenceDiscontinued
CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2003-04-02Labeling · Supplement 18 · standard — Label ↗AP
1997-08-08Manufacturing (CMC) · Supplement 16 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
1995-08-30Labeling · Supplement 10AP
1994-06-29Manufacturing (CMC) · Supplement 14 · standardAP
1994-06-07Manufacturing (CMC) · Supplement 13 · standardAP
1993-08-23Manufacturing (CMC) · Supplement 12 · standardAP
1993-03-05Manufacturing (CMC) · Supplement 11 · standardAP
1992-04-17Manufacturing (CMC) · Supplement 9 · standardAP
1989-12-07Labeling · Supplement 5AP
1989-12-07Labeling · Supplement 6AP
1989-09-15Labeling · Supplement 7AP
1987-07-10Manufacturing (CMC) · Supplement 3 · standardAP
1987-04-09Manufacturing (CMC) · Supplement 2 · standardAP
1987-03-03Manufacturing (CMC) · Supplement 4 · standardAP
1985-12-27Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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