FDA NDA · NDA011685

ARISTOCORT

Sponsor: FOSUN PHARMA

APPLICATION

NDA011685

TYPE

NDA

ORIGINAL APPROVAL

1959-03-12

LATEST ACTION

2024-06-05

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

ARISTOCORTDiscontinued

TRIAMCINOLONE DIACETATE 25MG/ML · INJECTABLE · INJECTION

2024-06-05Labeling · Supplement 27 · standard — Label ↗AP

2014-07-03Labeling · Supplement 26 · standard — Letter ↗AP

2001-08-29Manufacturing (CMC) · Supplement 24 · standardAP

1999-10-25Manufacturing (CMC) · Supplement 23 · standardAP

1995-11-09Manufacturing (CMC) · Supplement 22 · standardAP

1994-08-04Manufacturing (CMC) · Supplement 21 · standardAP

1993-09-07Labeling · Supplement 20AP

1992-11-05Manufacturing (CMC) · Supplement 18 · standardAP

1992-02-06Manufacturing (CMC) · Supplement 14 · standardAP

1992-02-06Manufacturing (CMC) · Supplement 19 · standardAP

1989-10-12Manufacturing (CMC) · Supplement 16 · standardAP

1980-10-06Manufacturing (CMC) · Supplement 12 · standardAP

1959-03-12Type 2 - New Active Ingredient · Original · standardAP

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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