Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018581
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/28/1982 | 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 |
|---|---|---|---|---|---|
| 01/16/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/22/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/14/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/12/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/12/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/10/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |