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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 022142

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022142

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

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

Therapeutic Equivalents for NDA 022142

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
SYMFI	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;300MG;300MG	TABLET;ORAL	Prescription	Yes	AB	022142	MYLAN LABS LTD

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