← FDA DRUG APPROVALS

FDA NDA · NDA019967

ULTRAVATE

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA019967
TYPE
NDA
ORIGINAL APPROVAL
1990-12-27
LATEST ACTION
2016-12-09
ROUTE
TOPICAL
DOSAGE FORM
CREAM
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HALOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2016-12-09Manufacturing (CMC) · Supplement 18 · standardAP
2016-02-24Manufacturing (CMC) · Supplement 17 · standardAP
2015-04-29Manufacturing (CMC) · Supplement 16 · standardAP
2012-04-02Labeling · Supplement 15 · unknown — Letter ↗AP
2004-09-17Labeling · Supplement 10 · standard — Letter ↗AP
2003-04-02Labeling · Supplement 4 — Review ↗AP
1996-10-04Manufacturing (CMC) · Supplement 8 · standardAP
1993-10-27Manufacturing (CMC) · Supplement 7 · standardAP
1993-08-25Manufacturing (CMC) · Supplement 2 · standardAP
1993-02-10Manufacturing (CMC) · Supplement 6 · standardAP
1992-07-14Manufacturing (CMC) · Supplement 5 · standardAP
1991-12-31Efficacy · Supplement 1AP
1991-12-30Manufacturing (CMC) · Supplement 3 · standardAP
1990-12-27Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →