Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018450
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROPRESS | SODIUM NITROPRUSSIDE | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/08/1981 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 09/21/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/20/1990 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/25/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/11/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/05/1984 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/23/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/31/1991 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |