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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208255
Company: MYLAN

Products on NDA 208255

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208255

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

Labels for NDA 208255

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

Therapeutic Equivalents for NDA 208255

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

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