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FDA NDA · NDA019968

ULTRAVATE

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA019968
TYPE
NDA
ORIGINAL APPROVAL
1990-12-17
LATEST ACTION
2013-05-17
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

ULTRAVATE · ReferenceDiscontinued
HALOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2013-05-17Manufacturing (CMC) · Supplement 12 · standardAP
2012-04-02Labeling · Supplement 11 · unknown — Letter ↗AP
2004-09-17Labeling · Supplement 7 · standard — Label ↗AP
1995-07-12Manufacturing (CMC) · Supplement 5 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 3 · standardAP
1993-10-27Manufacturing (CMC) · Supplement 4 · standardAP
1993-02-10Manufacturing (CMC) · Supplement 2 · standardAP
1991-12-31Efficacy · Supplement 1AP
1990-12-17Type 1 - New Molecular Entity · 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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