Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022142
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;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
03/22/2018 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022142s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022142Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022142Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022142s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022142Orig1s037ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022142s037lbl.pdf
03/22/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022142s000lbl.pdf

SYMFI

TABLET;ORAL; 600MG;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 600MG;300MG;300MG TABLET;ORAL Prescription No AB 212786 LAURUS LABS LTD
SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;300MG;300MG TABLET;ORAL Prescription Yes AB 022142 MYLAN LABS LTD

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