Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005794
Company: ORTHO MCNEIL PHARM

Products on NDA 005794

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005794

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.