← FDA DRUG APPROVALS

FDA NDA · NDA020340

TEMOVATE E

Sponsor: FOUGERA PHARMS

APPLICATION
NDA020340
TYPE
NDA
ORIGINAL APPROVAL
1994-06-17
LATEST ACTION
2012-11-15
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

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CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2012-11-15Labeling · Supplement 7 · standard — Letter ↗AP
2003-04-02Labeling · Supplement 6 · standard — Letter ↗AP
1997-08-08Manufacturing (CMC) · Supplement 4 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1996-05-03Efficacy · Supplement 1 · standardAP
1995-07-24Labeling · Supplement 2 · standardAP
1994-06-17Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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