← FDA DRUG APPROVALS

FDA NDA · NDA021835

CLOBEX

Sponsor: GALDERMA LABS LP

APPLICATION
NDA021835
TYPE
NDA
ORIGINAL APPROVAL
2005-10-27
LATEST ACTION
2018-12-21
ROUTE
TOPICAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

CLOBEX · ReferencePrescription
CLOBETASOL PROPIONATE 0.05% · SPRAY · TOPICAL

Approval history

2018-12-21Labeling · Supplement 15 · standard — Label ↗AP
2016-04-15Manufacturing (CMC) · Supplement 10 · standardAP
2015-05-21Manufacturing (CMC) · Supplement 9 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 8 · standardAP
2012-09-07Labeling · Supplement 6 · unknown — Label ↗AP
2012-08-17Labeling · Supplement 7 · unknown — Label ↗AP
2011-01-12Labeling · Supplement 4 · standard — Label ↗AP
2011-01-12Manufacturing (CMC) · Supplement 2 — Label ↗AP
2007-02-13Manufacturing (CMC) · Supplement 1AP
2005-10-27Type 3 - New Dosage Form · Original · standard — Label ↗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 →