Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 011601
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription AT Yes No
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription AT 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
10/23/1958 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
04/22/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

03/15/1996 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1987 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1986 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1984 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/18/1982 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/13/1982 SUPPL-36 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011601s036lbl.pdf
03/24/1980 SUPPL-35 Labeling

Label is not available on this site.

04/17/1979 SUPPL-34 Labeling

Label is not available on this site.

02/05/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1978 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/05/1978 SUPPL-31 Labeling

Label is not available on this site.

10/11/1977 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/11/1977 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1977 SUPPL-27 Labeling

Label is not available on this site.

05/27/1977 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1977 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/08/1976 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/28/1976 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/06/1975 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1974 SUPPL-18 Labeling

Label is not available on this site.

07/18/1974 SUPPL-17

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/13/1982 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011601s036lbl.pdf

TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL; 0.025%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 089797 ACP NIMBLE
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 207651 ALKEM LABS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 085692 FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 208763 LUPIN ATLANTIS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 209535 MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 040671 MLV
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription Yes AT 011601 MYLAN
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 086413 PERRIGO NEW YORK
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 210346 STRIDES PHARMA
TRIDERM TRIAMCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 088042 CROWN LABS

CREAM;TOPICAL; 0.1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 089798 ACP NIMBLE
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 207651 ALKEM LABS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 085692 FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 207117 GLENMARK PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 208763 LUPIN ATLANTIS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 209535 MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 040671 MLV
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription Yes AT 011601 MYLAN
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 086413 PERRIGO NEW YORK
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 086414 PERRIGO NEW YORK
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 210346 STRIDES PHARMA
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 040039 TARO PHARM INDS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 208848 TELIGENT PHARMA INC
TRIDERM TRIAMCINOLONE ACETONIDE 0.1% CREAM;TOPICAL Prescription No AT 088042 CROWN LABS

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