Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009182
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GANTRISIN | SULFISOXAZOLE ACETYL | EQ 500MG BASE/5ML | SYRUP;ORAL | Discontinued | None | No | No |
| GANTRISIN PEDIATRIC | SULFISOXAZOLE ACETYL | EQ 500MG BASE/5ML | SUSPENSION;ORAL | Discontinued | None | No | No |
| LIPO GANTRISIN | SULFISOXAZOLE ACETYL | EQ 1GM BASE/5ML | EMULSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/04/1953 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/31/1995 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/04/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 05/25/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/27/1978 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/22/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/11/1975 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |