Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 Prescription AT 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
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-Package Insert, Labeling-Container/Carton Labels

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

KENALOG

SPRAY;TOPICAL; 0.147MG/GM
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KENALOG TRIAMCINOLONE ACETONIDE 0.147MG/GM SPRAY;TOPICAL Prescription Yes AT 012104 SUN PHARM INDS INC
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.147MG/GM SPRAY;TOPICAL Prescription No AT 207094 AKORN
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.147MG/GM SPRAY;TOPICAL Prescription No AT 205782 PADAGIS ISRAEL
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.147MG/GM SPRAY;TOPICAL Prescription No AT 206786 RISING

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English