Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1985 | 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 |
|---|---|---|---|---|---|
| 07/29/2002 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-33 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/17/2001 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 01/17/2001 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-30 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-26 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/13/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/16/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/07/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |