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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213038
Company: LAURUS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 400MG;300MG;300MG TABLET;ORAL Prescription AB 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
05/14/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213038Orig1s000ltr.pdf

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 400MG;300MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 400MG;300MG;300MG TABLET;ORAL Prescription No AB 213038 LAURUS
SYMFI LO EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 400MG;300MG;300MG TABLET;ORAL Prescription Yes AB 208255 MYLAN
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