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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091612
Company: TEVA PHARMS USA

Products on ANDA 091612

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	AB	No	No
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	150MG	TABLET;ORAL	Prescription	AB	No	No
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET;ORAL	Prescription	AB	No	No
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091612

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091612Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2017	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/24/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
01/26/2018	SUPPL-1			Label is not available on this site.

Therapeutic Equivalents for ANDA 091612

TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	090647	AUROBINDO PHARMA
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	206481	CHARTWELL
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	078800	CIPLA
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	090636	HETERO LABS LTD III
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	203232	MACLEODS PHARMS LTD
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	079071	MYLAN LABS LTD
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	209498	QILU
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	211337	REYOUNG
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	090742	STRIDES PHARMA
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	091612	TEVA PHARMS USA
VIREAD	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	Yes	AB	021356	GILEAD SCIENCES INC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	150MG	TABLET;ORAL	Prescription	No	AB	090647	AUROBINDO PHARMA
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	150MG	TABLET;ORAL	Prescription	No	AB	091612	TEVA PHARMS USA
VIREAD	TENOFOVIR DISOPROXIL FUMARATE	150MG	TABLET;ORAL	Prescription	Yes	AB	021356	GILEAD SCIENCES INC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET;ORAL	Prescription	No	AB	090647	AUROBINDO PHARMA
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET;ORAL	Prescription	No	AB	209498	QILU
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET;ORAL	Prescription	No	AB	091612	TEVA PHARMS USA
VIREAD	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET;ORAL	Prescription	Yes	AB	021356	GILEAD SCIENCES INC

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET;ORAL	Prescription	No	AB	090647	AUROBINDO PHARMA
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET;ORAL	Prescription	No	AB	209498	QILU
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET;ORAL	Prescription	No	AB	091612	TEVA PHARMS USA
VIREAD	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET;ORAL	Prescription	Yes	AB	021356	GILEAD SCIENCES INC

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