Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087191
Company: ALPHARMA US PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% LOTION;TOPICAL Discontinued None No 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
09/08/1982 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/02/1992 SUPPL-20 Labeling

Label is not available on this site.

02/06/1990 SUPPL-19 Labeling

Label is not available on this site.

04/26/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/26/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/16/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/16/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/16/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/21/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/09/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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