Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040445
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription AB No 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
03/31/2010 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040445s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/040445Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2013 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/040445Orig1s003Approv.pdf

METAXALONE

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription No AB 203695 ACTAVIS LABS FL INC
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription No AB 203399 AMNEAL PHARMS
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription No AB 208774 APPCO PHARMA LLC
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription No AB 204770 LANNETT CO INC
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription No AB 040445 SANDOZ
METAXALONE METAXALONE 800MG TABLET;ORAL Prescription No AB 207466 SCIEGEN PHARMS INC
SKELAXIN METAXALONE 800MG TABLET;ORAL Prescription Yes AB 013217 KING PHARMS

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