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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013217
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SKELAXIN METAXALONE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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 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
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
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
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