Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012802
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE DIACETATE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/05/1961 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012802Orig1s033ltr.pdf
09/04/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/14/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012802s031ltr.pdf
08/29/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1993 SUPPL-24 Labeling

Label is not available on this site.

01/06/1992 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1992 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1989 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/17/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf
01/17/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf
10/03/1980 SUPPL-13 Manufacturing (CMC)

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-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf
01/14/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf

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