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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213681
Company: LAURUS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE UNKNOWN UNKNOWN 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
12/04/2020 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/2020/213681Orig1s000TAltr.pdf
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