← FDA DRUG APPROVALS

FDA ANDA · ANDA088451

TRIAMCINOLONE ACETONIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA088451
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-03
LATEST ACTION
2014-11-10
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription

Products

TRIAMCINOLONE ACETONIDEPrescription
TRIAMCINOLONE ACETONIDE 0.1% · LOTION · TOPICAL

Approval history

2014-11-10Manufacturing (CMC) · Supplement 13AP
1996-08-01Labeling · Supplement 11AP
1996-08-01Manufacturing (CMC) · Supplement 9AP
1996-08-01Manufacturing (CMC) · Supplement 10AP
1993-12-27Labeling · Supplement 8AP
1992-03-12Labeling · Supplement 7AP
1990-01-25Labeling · Supplement 6AP
1986-05-29Manufacturing (CMC) · Supplement 2AP
1985-04-03OriginalAP
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 →