Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006525
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GANTRISIN | SULFISOXAZOLE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1948 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/04/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/09/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/27/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |