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FDA NDA · NDA012802

ARISTOCORT

Sponsor: FOSUN PHARMA

APPLICATION
NDA012802
TYPE
NDA
ORIGINAL APPROVAL
1961-09-05
LATEST ACTION
2024-06-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ARISTOCORT · ReferenceDiscontinued
TRIAMCINOLONE DIACETATE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-06-05Labeling · Supplement 34 · standard — Label ↗AP
2014-09-04Manufacturing (CMC) · Supplement 32 · standardAP
2014-07-03Labeling · Supplement 33 · standard — Letter ↗AP
2010-01-14Labeling · Supplement 31 · standard — Letter ↗AP
2003-01-17Labeling · Supplement 16 — Letter ↗AP
2003-01-17Labeling · Supplement 14 — Letter ↗AP
2001-08-29Manufacturing (CMC) · Supplement 28 · standardAP
1999-10-25Manufacturing (CMC) · Supplement 27 · standardAP
1995-11-09Manufacturing (CMC) · Supplement 26 · standardAP
1994-08-04Manufacturing (CMC) · Supplement 25 · standardAP
1993-09-07Labeling · Supplement 24AP
1992-11-05Manufacturing (CMC) · Supplement 22 · standardAP
1992-02-06Manufacturing (CMC) · Supplement 17 · standardAP
1992-01-22Manufacturing (CMC) · Supplement 21 · standardAP
1992-01-06Manufacturing (CMC) · Supplement 23 · standardAP
1989-10-12Manufacturing (CMC) · Supplement 19 · standardAP
1980-10-03Manufacturing (CMC) · Supplement 13 · standardAP
1961-09-05Type 5 - New Formulation or New Manufacturer · Original · standardAP
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