Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005794
Company: ORTHO MCNEIL PHARM
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. |
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11/01/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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09/12/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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06/25/1992 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1992 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/22/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |