Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022343
Company: AUROBINDO PHARMA LTD

Products on NDA 022343

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	600MG;300MG;300MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022343

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/2018	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022343s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022343Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022343Orig1s000TOC.cfm

Labels for NDA 022343

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022343s000lbl.pdf