← FDA DRUG APPROVALS

FDA ANDA · ANDA200735

FLUOCINONIDE

Sponsor: FOUGERA PHARMS INC

APPLICATION
ANDA200735
TYPE
ANDA
ORIGINAL APPROVAL
2014-07-14
LATEST ACTION
2015-09-18
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

FLUOCINONIDEPrescription
FLUOCINONIDE 0.1% · CREAM · TOPICAL

Approval history

2015-09-18Manufacturing (CMC) · Supplement 1 · unknownAP
2014-07-14OriginalLetterAP
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 →