Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018531
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/06/1981 | 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 |
|---|---|---|---|---|---|
| 08/30/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/12/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/14/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 06/14/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/08/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 12/01/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/05/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/24/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/27/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |