Drugs@FDA: FDA-Approved Drugs
Company: AUXILIUM PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROBAXIN | METHOCARBAMOL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ROBAXIN-750 | METHOCARBAMOL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/16/1957 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 03/01/2019 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011011Orig1s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011011Orig1s079ltr.pdf | |
| 03/09/2015 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/2003 | SUPPL-71 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/011011Orig1s070,s071ltr.pdf | |
| 05/01/2003 | SUPPL-70 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/011011Orig1s070,s071ltr.pdf | |
| 04/22/1998 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1990 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1984 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1983 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1983 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1982 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1982 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1982 | SUPPL-49 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1981 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/24/1981 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1982 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1982 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/22/1981 | SUPPL-41 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/22/1981 | SUPPL-40 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/07/1981 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/28/1981 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1979 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1979 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/21/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/10/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1974 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/29/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1975 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/1974 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/17/1974 | SUPPL-8 | 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 |
|---|---|---|---|---|---|
| 03/01/2019 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011011Orig1s079lbl.pdf | |
| 05/01/2003 | SUPPL-71 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf | |
| 05/01/2003 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf |