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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206481
Company: CHARTWELL

Products on ANDA 206481

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206481

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2018	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
11/20/2019	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/20/2019	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/20/2019	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/20/2019	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206481

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	206157	MICRO LABS
TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET;ORAL	Prescription	No	AB	079071	PHARMOBEDIENT
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

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