Drugs@FDA: FDA-Approved Drugs
Company: MYLAN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 06/12/1986 | 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 |
|---|---|---|---|---|---|
| 09/21/2000 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-29 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 10/13/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/18/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |