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FDA NDA · NDA011601

TRIAMCINOLONE ACETONIDE

Sponsor: NORVIUM BIOSCIENCE

APPLICATION
NDA011601
TYPE
NDA
ORIGINAL APPROVAL
1958-10-23
LATEST ACTION
2016-04-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

TRIAMCINOLONE ACETONIDE · ReferenceDiscontinued
TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
TRIAMCINOLONE ACETONIDE · ReferenceDiscontinued
TRIAMCINOLONE ACETONIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2016-04-22Manufacturing (CMC) · Supplement 43 · standardAP
1996-03-15Manufacturing (CMC) · Supplement 42 · standardAP
1987-06-04Manufacturing (CMC) · Supplement 40 · standardAP
1986-04-15Manufacturing (CMC) · Supplement 39 · standardAP
1984-08-08Manufacturing (CMC) · Supplement 38 · standardAP
1982-12-13Labeling · Supplement 36LabelAP
1982-03-18Manufacturing (CMC) · Supplement 37 · standardAP
1980-03-24Labeling · Supplement 35AP
1979-04-17Labeling · Supplement 34AP
1979-02-05Manufacturing (CMC) · Supplement 33 · standardAP
1978-11-13Manufacturing (CMC) · Supplement 32 · standardAP
1978-07-05Labeling · Supplement 31AP
1977-10-11Manufacturing (CMC) · Supplement 28 · standardAP
1977-10-11Manufacturing (CMC) · Supplement 29 · standardAP
1977-05-27Manufacturing (CMC) · Supplement 26 · standardAP
1977-05-23Labeling · Supplement 27AP
1977-01-31Manufacturing (CMC) · Supplement 25 · standardAP
1976-07-08Manufacturing (CMC) · Supplement 24 · standardAP
1976-04-28Manufacturing (CMC) · Supplement 23 · standardAP
1975-03-06Manufacturing (CMC) · Supplement 20 · standardAP
1975-03-06Manufacturing (CMC) · Supplement 19 · standardAP
1974-09-13Labeling · Supplement 18AP
1974-07-18Supplement · Supplement 17 · standardAP
1958-10-23Type 3 - New Dosage Form · Original · standardAP
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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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