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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208195
Company: YUNG SHIN PHARM

Products on ANDA 208195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	AB	No	No
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2021	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
12/23/2024	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 208195

ENTECAVIR

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BARACLUDE	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	Yes	AB	021797	BRISTOL MYERS SQUIBB
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	206652	AMNEAL PHARMS
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	206217	AUROBINDO PHARMA
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	212126	BRIGHTGENE
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	206872	CIPLA
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	216857	CONBA USA
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	205740	HETERO LABS LTD V
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	208195	YUNG SHIN PHARM
ENTECAVIR	ENTECAVIR	0.5MG	TABLET;ORAL	Prescription	No	AB	206745	ZYDUS PHARMS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BARACLUDE	ENTECAVIR	1MG	TABLET;ORAL	Prescription	Yes	AB	021797	BRISTOL MYERS SQUIBB
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	206652	AMNEAL PHARMS
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	206217	AUROBINDO PHARMA
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	212126	BRIGHTGENE
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	206872	CIPLA
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	216857	CONBA USA
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	205740	HETERO LABS LTD V
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	208195	YUNG SHIN PHARM
ENTECAVIR	ENTECAVIR	1MG	TABLET;ORAL	Prescription	No	AB	206745	ZYDUS PHARMS

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