Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022142
Company: MYLAN LABS LTD

Products on NDA 22142

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

Labels for NDA 022142

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