← FDA DRUG APPROVALS

FDA NDA · NDA019966

TEMOVATE

Sponsor: FOUGERA PHARMS

APPLICATION
NDA019966
TYPE
NDA
ORIGINAL APPROVAL
1990-02-22
LATEST ACTION
2003-04-03
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
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CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2003-04-03Labeling · Supplement 8 · standard — Label ↗AP
1997-08-08Manufacturing (CMC) · Supplement 6 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 5 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 4 · standardAP
1994-06-07Manufacturing (CMC) · Supplement 3 · standardAP
1993-08-23Manufacturing (CMC) · Supplement 2 · standardAP
1992-04-17Manufacturing (CMC) · Supplement 1 · standardAP
1990-02-22Type 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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