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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213509
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 400MG; 200MG; 25MG TABLET; ORAL None (Tentative Approval) None 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
03/22/2024 ORIG-1 Tentative Approval Type 4 - New Combination STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213509Orig1s000TAltr.pdf
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