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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012104
Company: SUN PHARM INDS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KENALOG TRIAMCINOLONE ACETONIDE 0.147MG/GM SPRAY;TOPICAL 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
10/11/1974 ORIG-1 Approval Type 3 - New Dosage Form 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
01/26/2017 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
10/06/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
11/15/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
06/21/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
08/01/2011 SUPPL-32 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012104s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012104s032ltr.pdf
08/20/2009 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
10/12/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
03/05/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
09/23/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
06/04/1987 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
08/23/1985 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/11/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
10/06/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
08/20/1982 SUPPL-21 Labeling

Label is not available on this site.
07/21/1980 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
10/02/1979 SUPPL-19 Labeling

Label is not available on this site.
03/16/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
07/05/1978 SUPPL-17 Labeling

Label is not available on this site.
10/11/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
10/11/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
06/23/1977 SUPPL-13 Labeling

Label is not available on this site.
02/04/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
10/18/1976 SUPPL-11 Labeling

Label is not available on this site.
10/11/1974 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/01/2011 SUPPL-32 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012104s032lbl.pdf
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