← FDA DRUG APPROVALS

FDA ANDA · ANDA088168

FLUOCINOLONE ACETONIDE

Sponsor: FOUGERA PHARMS INC

APPLICATION
ANDA088168
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-16
LATEST ACTION
1996-03-07
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.025% · OINTMENT · TOPICAL

Approval history

1996-03-07Manufacturing (CMC) · Supplement 5AP
1988-03-09Manufacturing (CMC) · Supplement 2AP
1987-05-28Manufacturing (CMC) · Supplement 4AP
1987-05-28Manufacturing (CMC) · Supplement 3AP
1982-12-16OriginalAP
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 →