← FDA DRUG APPROVALS

FDA ANDA · ANDA062364

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA062364
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-22
LATEST ACTION
2007-09-04
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

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

Approval history

2007-09-04Manufacturing (CMC) · Supplement 17AP
2001-03-19Manufacturing (CMC) · Supplement 11AP
1997-05-27Manufacturing (CMC) · Supplement 10AP
1996-09-17Manufacturing (CMC) · Supplement 9AP
1996-04-30Manufacturing (CMC) · Supplement 7AP
1995-08-24Manufacturing (CMC) · Supplement 8AP
1994-10-19Manufacturing (CMC) · Supplement 4AP
1993-12-03Labeling · Supplement 6AP
1993-03-16Manufacturing (CMC) · Supplement 5AP
1992-10-30Labeling · Supplement 3AP
1989-12-07Manufacturing (CMC) · Supplement 2AP
1988-09-12Manufacturing (CMC) · Supplement 1AP
1987-12-22OriginalAP
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 →