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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012041
Company: APOTHECON

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KENALOG-10 TRIAMCINOLONE ACETONIDE 10MG/ML INJECTABLE;INJECTION Prescription 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
01/04/1960 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
06/22/2018 SUPPL-45 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012041Orig1s045ltr.pdf
03/29/2018 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012041Orig1s044ltr.pdf
10/26/2015 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
07/03/2014 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012041Orig1s042,014901Orig1s042ltr.pdf
07/15/2011 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf
06/16/2011 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/012041Orig1s038.pdf
01/28/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012041s036,014901s037ltr.pdf
06/15/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
11/20/2006 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012041s033ltr.pdf
02/03/1998 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
05/22/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
01/10/1995 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
08/30/1993 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/30/1993 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/06/1993 SUPPL-27 Labeling

Label is not available on this site.
09/25/1991 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
07/19/1991 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/19/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
11/30/1987 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
12/03/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
04/01/1981 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
08/21/1979 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
05/20/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
07/17/1979 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
09/19/1977 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
01/12/1982 SUPPL-14 Labeling

Label is not available on this site.
12/28/1978 SUPPL-13 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/22/2018 SUPPL-45 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf
06/22/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf
03/29/2018 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s044lbl.pdf
07/03/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf
07/15/2011 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf
06/16/2011 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf
01/28/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf
11/20/2006 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf
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