← FDA DRUG APPROVALS

FDA NDA · NDA208183

HALOBETASOL PROPIONATE

Sponsor: LACER PHARMA

APPLICATION
NDA208183
TYPE
NDA
ORIGINAL APPROVAL
2015-11-06
LATEST ACTION
2020-08-27
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription

Products

ULTRAVATE · ReferencePrescription
HALOBETASOL PROPIONATE 0.05% · LOTION · TOPICAL

Approval history

2020-08-27Efficacy · Supplement 2 · standardLetterAP
2015-11-06Type 3 - New Dosage Form · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →