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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213541
Company: LAURUS

Products on ANDA 213541

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213541

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213541

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 600MG;200MG;300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	No	AB	203041	AUROBINDO PHARMA
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	No	AB	206894	CIPLA
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	No	AB	203053	HETERO LABS LTD V
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	No	AB	213541	LAURUS
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	No	AB	204287	MACLEODS PHARMS LTD
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET;ORAL	Prescription	No	AB	091215	TEVA PHARMS USA

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