Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087285
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPLE SULFA TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) 3.7%;2.86%;3.42% CREAM;VAGINAL 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
11/15/1982 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
09/16/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/07/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/04/1992 SUPPL-10 Labeling

Label is not available on this site.

08/07/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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