Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005794
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULTRIN TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) 3.7%;2.86%;3.42% CREAM;VAGINAL Discontinued None No No
SULTRIN TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) 184MG;143.75MG;172.5MG TABLET;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
09/12/1945 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
05/15/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/12/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/25/1992 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1991 SUPPL-18 Labeling

Label is not available on this site.

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