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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211640
Company: AUROBINDO PHARMA LTD

Products on ANDA 211640

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET;ORAL	Prescription	AB	No	No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET;ORAL	Prescription	AB	No	No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211640

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211640

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 100MG;150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET;ORAL	Prescription	No	AB	209721	AMNEAL PHARMS CO
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET;ORAL	Prescription	No	AB	211640	AUROBINDO PHARMA LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET;ORAL	Prescription	No	AB	212689	ZYDUS PHARMS
TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET;ORAL	Prescription	Yes	AB	021752	GILEAD

TABLET;ORAL; 133MG;200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET;ORAL	Prescription	No	AB	209721	AMNEAL PHARMS CO
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET;ORAL	Prescription	No	AB	211640	AUROBINDO PHARMA LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET;ORAL	Prescription	No	AB	212689	ZYDUS PHARMS
TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET;ORAL	Prescription	Yes	AB	021752	GILEAD

TABLET;ORAL; 167MG;250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET;ORAL	Prescription	No	AB	209721	AMNEAL PHARMS CO
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET;ORAL	Prescription	No	AB	211640	AUROBINDO PHARMA LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET;ORAL	Prescription	No	AB	212689	ZYDUS PHARMS
TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET;ORAL	Prescription	Yes	AB	021752	GILEAD

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