Drugs@FDA: FDA-Approved Drugs

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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ROBAXIN METHOCARBAMOL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
ROBAXIN-750 METHOCARBAMOL 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
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

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