Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209721
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET;ORAL Discontinued None No No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET;ORAL Discontinued None No No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET;ORAL Discontinued None No No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Discontinued 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
08/22/2018 ORIG-1 Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209721Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2019 SUPPL-1 REMS - MODIFIED - D-N-A

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