Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071848
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROGLYCERIN IN DEXTROSE 5% | NITROGLYCERIN | 40MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1990 | 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 |
|---|---|---|---|---|---|
| 10/27/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/31/2001 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/31/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/31/2001 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/14/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |