← FDA DRUG APPROVALS

FDA ANDA · ANDA062602

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Sponsor: FOUGERA PHARMS INC

APPLICATION
ANDA062602
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-09
LATEST ACTION
2002-09-19
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

NYSTATIN AND TRIAMCINOLONE ACETONIDEPrescription
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · OINTMENT · TOPICAL

Approval history

2002-09-19Manufacturing (CMC) · Supplement 4AP
2002-03-07Manufacturing (CMC) · Supplement 5AP
1996-03-07Manufacturing (CMC) · Supplement 3AP
1993-04-28Labeling · Supplement 1AP
1985-10-09OriginalAP
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 →