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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022503
Company: PRIMUS PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METAXALONE METAXALONE 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
06/01/2015 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022503s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022503Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022503Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022503Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2024 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022503s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022503Orig1s003ltr.pdf
02/25/2022 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022503s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022503Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/10/2024 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022503s003lbl.pdf
02/25/2022 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022503s001lbl.pdf
06/01/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022503s000lbl.pdf
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