← FDA DRUG APPROVALS

FDA NDA · NDA021644

CLOBETASOL PROPIONATE

Sponsor: GALDERMA LABS

APPLICATION
NDA021644
TYPE
NDA
ORIGINAL APPROVAL
2004-02-05
LATEST ACTION
2012-11-30
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Prescription

Products

CLOBEX · ReferencePrescription
CLOBETASOL PROPIONATE 0.05% · SHAMPOO · TOPICAL

Approval history

2012-11-30Labeling · Supplement 3 · unknown — Letter ↗AP
2012-08-17Labeling · Supplement 2 · unknown — Letter ↗AP
2004-02-05Type 3 - New Dosage Form · Original · standard — Review ↗AP
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 →