Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011685
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE DIACETATE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/12/1959 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/03/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011685Orig1s026ltr.pdf
08/29/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1993 SUPPL-20 Labeling

Label is not available on this site.

02/06/1992 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1992 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/06/1980 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/03/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf

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