Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212114
Company: LAURUS

Products on ANDA 212114

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212114

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2025	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/18/2025	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/18/2025	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/18/2025	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/18/2025	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 212114

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 200MG;300MG
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	200MG;300MG	TABLET;ORAL	Prescription	No	AB	201806	HETERO LABS LTD III
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	209721	AMNEAL PHARMS CO
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	090513	AUROBINDO PHARMA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	204131	CHARTWELL RX
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	212114	LAURUS
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	203442	MACLEODS PHARMS LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	206436	PHARMOBEDIENT
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	091055	STRIDES PHARMA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	090894	TEVA PHARMS USA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	No	AB	212689	ZYDUS PHARMS
TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET;ORAL	Prescription	Yes	AB	021752	GILEAD