Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083101
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPOXYPHENE COMPOUND-65 | ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE | 389MG;32.4MG;65MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/15/1976 | 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 |
|---|---|---|---|---|---|
| 04/04/1995 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1992 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1989 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 06/08/1989 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 06/14/1991 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1987 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1987 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1986 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1986 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1985 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1984 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1984 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1985 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |