Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208255
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMFI LO EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 400MG;300MG;300MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/05/2018 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208255s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208255Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208255Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208255s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208255Orig1s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208255s008lbl.pdf
02/05/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208255s000lbl.pdf

SYMFI LO

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 LABS LTD
SYMFI LO EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 400MG;300MG;300MG TABLET;ORAL Prescription Yes AB 208255 MYLAN

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