Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017546
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIPRIDE | SODIUM NITROPRUSSIDE | 50MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/1974 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/18/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/27/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/30/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/13/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/23/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/27/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |