APPLICATION
ANDA085692
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-09
LATEST ACTION
1997-08-12
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
TRIAMCINOLONE ACETONIDE · ReferencePrescription
TRIAMCINOLONE ACETONIDE 0.5% · CREAM · TOPICAL
TRIAMCINOLONE ACETONIDE · ReferencePrescription
TRIAMCINOLONE ACETONIDE 0.1% · CREAM · TOPICAL
TRIAMCINOLONE ACETONIDE · ReferencePrescription
TRIAMCINOLONE ACETONIDE 0.025% · CREAM · TOPICAL
Approval history
1997-08-12Manufacturing (CMC) · Supplement 52AP
1996-03-07Manufacturing (CMC) · Supplement 51AP
1995-06-01Manufacturing (CMC) · Supplement 49AP
1995-05-09Manufacturing (CMC) · Supplement 50AP
1993-08-24Manufacturing (CMC) · Supplement 48AP
1988-05-20Manufacturing (CMC) · Supplement 44AP
1988-03-03Manufacturing (CMC) · Supplement 42AP
1986-12-02Manufacturing (CMC) · Supplement 40AP
1984-07-26Manufacturing (CMC) · Supplement 39AP
1983-09-14Manufacturing (CMC) · Supplement 38AP
1983-05-26Manufacturing (CMC) · Supplement 37AP
1983-05-26Manufacturing (CMC) · Supplement 36AP
1978-03-09OriginalAP
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.
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