Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213556
Company: SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 50MG; 300MG; 300MG 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
10/06/2020 ORIG-1 Tentative Approval Type 4 - New Combination STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213556Orig1s000TA_ltr.pdf

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