Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 011011
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ROBAXIN	METHOCARBAMOL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ROBAXIN-750	METHOCARBAMOL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	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