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FDA NDA · NDA011161

ARISTOCORT

Sponsor: ASTELLAS

APPLICATION
NDA011161
TYPE
NDA
ORIGINAL APPROVAL
1957-12-03
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ARISTOCORTDiscontinued
TRIAMCINOLONE 1MG · TABLET · ORAL
ARISTOCORTDiscontinued
TRIAMCINOLONE 4MG · TABLET · ORAL
ARISTOCORTDiscontinued
TRIAMCINOLONE 8MG · TABLET · ORAL
ARISTOCORTDiscontinued
TRIAMCINOLONE 2MG · TABLET · ORAL
ARISTOCORTDiscontinued
TRIAMCINOLONE 16MG · TABLET · ORAL

Approval history

2009-03-13Labeling · Supplement 47AP
2009-03-13Labeling · Supplement 39AP
2009-03-13Labeling · Supplement 44AP
1999-09-17Manufacturing (CMC) · Supplement 51 · priorityAP
1994-10-18Manufacturing (CMC) · Supplement 50 · priorityAP
1994-03-30Manufacturing (CMC) · Supplement 48 · priorityAP
1993-09-07Labeling · Supplement 49AP
1986-11-29Manufacturing (CMC) · Supplement 45 · priorityAP
1986-09-25Manufacturing (CMC) · Supplement 46 · priorityAP
1982-06-11Manufacturing (CMC) · Supplement 43 · priorityAP
1981-04-27Manufacturing (CMC) · Supplement 42 · priorityAP
1979-08-06Manufacturing (CMC) · Supplement 40 · priorityAP
1957-12-03Type 1 - New Molecular Entity · Original · priorityAP
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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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