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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090513
Company: AUROBINDO PHARMA

Products on ANDA 090513

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 090513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2018	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090513s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090513Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/01/2019	SUPPL-13	REMS - MODIFIED - D-N-A		Label is not available on this site.
01/14/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/24/2018	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 090513

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	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

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