Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016466
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOSPAN TRIAMCINOLONE HEXACETONIDE 5MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
ARISTOSPAN TRIAMCINOLONE HEXACETONIDE 20MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/1969 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-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016466Orig1s046ltr.pdf
09/04/2014 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/03/2009 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf
06/03/2009 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf
03/01/2007 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016466s036ltr.pdf
02/12/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1999 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1995 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1994 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016466s027ltr.pdf
09/07/1993 SUPPL-26 Labeling

Label is not available on this site.

01/06/1992 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1991 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1990 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1985 SUPPL-17 Labeling

Label is not available on this site.

10/07/1980 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/04/1978 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/18/1979 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/13/1979 SUPPL-12 Labeling

Label is not available on this site.

04/18/1979 SUPPL-11 Labeling

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-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf
06/03/2009 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf
06/03/2009 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf
03/01/2007 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf
02/01/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf

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