Drugs@FDA: FDA-Approved Drugs
Company: KING PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SKELAXIN | METAXALONE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
SKELAXIN | METAXALONE | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/13/1962 | 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 |
---|---|---|---|---|---|
06/21/2024 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013217s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/013217Orig1s062ltr.pdf | |
05/09/2016 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/06/2018 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013217s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/013217Orig1s057ltr.pdf | |
09/29/2014 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/27/2014 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/2008 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013217s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013217s053ltr.pdf | |
11/24/2006 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013217s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013217s046ltr.pdf | |
06/03/2002 | SUPPL-45 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217_S045_SKELAXIN.pdf |
06/20/2002 | SUPPL-44 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13217s044ltr_2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217s044_SkelexinTOC.cfm |
04/16/2002 | SUPPL-43 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217_S043_SKELAXIN.pdf |
09/26/2001 | SUPPL-41 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013217_S041_SKELAXIN.pdf |
01/31/2001 | SUPPL-40 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013217_S040_SKELAXIN.pdf |
05/04/2000 | SUPPL-37 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/013217_S037_SKELAXIN.pdf |
08/30/2002 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/13217s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13217scf036LTR.pdf | |
09/18/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/1999 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/26/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/1999 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/20/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/07/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/28/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/27/1995 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/05/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/27/1992 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/28/1989 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/26/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/31/1985 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/31/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
03/27/1984 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/27/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/16/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/16/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
04/15/1980 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/13/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/26/1979 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
04/04/1977 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/21/2024 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013217s062lbl.pdf | |
03/06/2018 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013217s057lbl.pdf | |
10/31/2008 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013217s053lbl.pdf | |
11/24/2006 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013217s046lbl.pdf | |
08/30/2002 | SUPPL-36 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/13217s036lbl.pdf |