Drugs@FDA: FDA-Approved Drugs
Company: XANODYNE PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DARVOCET-N 100 | ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | 650MG;100MG | TABLET;ORAL | Discontinued | None | No | No |
| DARVOCET-N 50 | ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | 325MG;50MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/1972 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/25/2009 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf | |
| 09/25/2009 | SUPPL-61 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf | |
| 01/24/2007 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/2006 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2005 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2005 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2005 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1999 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1998 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1998 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/15/1997 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 03/14/1995 | SUPPL-45 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/05/1994 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1994 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 09/15/1992 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1993 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/23/1994 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/20/1995 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 04/16/1987 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/21/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/03/1986 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/16/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1984 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/28/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/20/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/26/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/06/1979 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/29/1979 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/16/1978 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1977 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/06/1977 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/10/1977 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/15/1976 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/18/1974 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/25/2009 | SUPPL-62 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf | |
| 09/25/2009 | SUPPL-61 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf |