Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018621
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITRO-BID | NITROGLYCERIN | 5MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/05/1982 | 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 |
|---|---|---|---|---|---|
| 09/29/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/11/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/18/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |