Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072034
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 5MG/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/24/1988 | 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 |
|---|---|---|---|---|---|
| 07/21/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/05/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/13/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/19/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |