Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011600
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No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
07/30/1963 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
03/18/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1993 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/1987 SUPPL-26 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf
08/09/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/08/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/10/1983 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1982 SUPPL-21 Labeling

Label is not available on this site.

07/05/1978 SUPPL-20 Labeling

Label is not available on this site.

01/23/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1977 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/11/1977 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1977 SUPPL-16 Labeling

Label is not available on this site.

02/04/1977 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1975 SUPPL-12 Labeling

Label is not available on this site.

07/08/1974 SUPPL-10

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/1987 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf

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