Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087355
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 2% | OINTMENT;TRANSDERMAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/28/1981 | 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 |
|---|---|---|---|---|---|
| 06/25/2020 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/05/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/06/2004 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/09/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/30/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/20/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |