Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014901
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KENALOG-40 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription AB Yes Yes
KENALOG-80 TRIAMCINOLONE ACETONIDE 80MG/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
02/01/1965 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
04/12/2019 SUPPL-47 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/014901Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/014901Orig1s047ltr.pdf
06/22/2018 SUPPL-45 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s045lbl.pdf
03/29/2018 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014901Orig1s044ltr.pdf
10/26/2015 SUPPL-43 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/014901Orig1s043.pdf
07/03/2014 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.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/2011/014901s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf
06/16/2011 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf
01/28/2010 SUPPL-37 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/2010/012041s036,01401s037ltr.pdf
01/05/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/20/2006 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014901s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/014901_S034_Kenalog_40.pdf
05/22/1996 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1995 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1994 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1991 SUPPL-29 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S029_Kenalog_40.pdf
02/14/1992 SUPPL-28 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S028_Kenalog.pdf
11/19/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/30/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/14/1985 SUPPL-25 Labeling

Label is not available on this site.

04/13/1984 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/04/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/30/1982 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)-Control

Label is not available on this site.

04/07/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1978 SUPPL-10 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S010_Kenalog_40.pdf
07/27/1979 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S009_Kenalog_40.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/12/2019 SUPPL-47 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/014901Orig1s047lbl.pdf
06/22/2018 SUPPL-45 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s045lbl.pdf
03/29/2018 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s044lbl.pdf
07/03/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.pdf
07/15/2011 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s039lbl.pdf
06/16/2011 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf
01/28/2010 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf
11/20/2006 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf

KENALOG-40

INJECTABLE;INJECTION; 40MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KENALOG-40 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription Yes AB 014901 APOTHECON
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription No AB 207550 AMNEAL
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription No AB 209852 TEVA PHARMS USA

KENALOG-80

There are no Therapeutic Equivalents.

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