APPLICATION
ANDA040037
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-30
LATEST ACTION
2016-10-26
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
TRIAMCINOLONE ACETONIDEPrescription
TRIAMCINOLONE ACETONIDE 0.1% · OINTMENT · TOPICAL
Approval history
2016-10-26Manufacturing (CMC) · Supplement 16 · unknownAP
1998-06-30Manufacturing (CMC) · Supplement 7AP
1997-11-28Manufacturing (CMC) · Supplement 5AP
1997-11-28Manufacturing (CMC) · Supplement 6AP
1997-11-28Manufacturing (CMC) · Supplement 4AP
1996-09-17Manufacturing (CMC) · Supplement 2AP
1995-12-15Manufacturing (CMC) · Supplement 1AP
1994-09-30OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.