← FDA DRUG APPROVALS

FDA NDA · NDA018726

WESTCORT

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA018726
TYPE
NDA
ORIGINAL APPROVAL
1983-08-08
LATEST ACTION
2002-09-03
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

WESTCORT · ReferenceDiscontinued
HYDROCORTISONE VALERATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2002-09-03Labeling · Supplement 9 · standard — Letter ↗AP
2002-09-03Labeling · Supplement 12 · standard — Letter ↗AP
1993-02-22Manufacturing (CMC) · Supplement 8 · standardAP
1991-12-30Manufacturing (CMC) · Supplement 7 · standardAP
1985-01-03Manufacturing (CMC) · Supplement 4 · standardAP
1984-08-21Manufacturing (CMC) · Supplement 3 · standardAP
1984-06-27Manufacturing (CMC) · Supplement 2 · standardAP
1983-08-08Type 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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