Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012715
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GANTANOL | SULFAMETHOXAZOLE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| GANTANOL-DS | SULFAMETHOXAZOLE | 1GM | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/25/1965 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 09/17/2001 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 09/17/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 05/04/1978 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/05/1978 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/04/1977 | SUPPL-19 | Labeling |
Label is not available on this site. |