Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088607
Company: G AND W LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GYNE-SULF 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
06/09/1986 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
11/08/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/23/1990 SUPPL-8 Labeling

Label is not available on this site.

09/20/1991 SUPPL-7 Labeling

Label is not available on this site.

12/19/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/19/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/13/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/13/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/13/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/13/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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