Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070443
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN | ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | 650MG;100MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/23/1987 | 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 |
|---|---|---|---|---|---|
| 05/15/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |