← FDA DRUG APPROVALS

FDA NDA · NDA020337

TEMOVATE

Sponsor: FOUGERA PHARMS

APPLICATION
NDA020337
TYPE
NDA
ORIGINAL APPROVAL
1994-04-29
LATEST ACTION
2003-04-02
ROUTE
TOPICAL
DOSAGE FORM
GEL
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CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL

Approval history

2003-04-02Labeling · Supplement 5 · standard — Label ↗AP
1998-06-05Manufacturing (CMC) · Supplement 3 · standardAP
1997-08-08Manufacturing (CMC) · Supplement 2 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1994-04-29Type 3 - New Dosage Form · Original · standardAP
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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