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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204574
Company: HETERO LABS LTD V

Products on ANDA 204574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	AB	No	No
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204574Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204574

TETRABENAZINE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	206093	APOTEX
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	208826	BIONPHARMA INC
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	209284	DR REDDYS
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	204574	HETERO LABS LTD V
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	210544	LUPIN LTD
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	207682	MYLAN
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	213316	PIRAMAL HLTHCARE UK
XENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	Yes	AB	021894	BAUSCH

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	206686	ACTAVIS LABS FL INC
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	206093	APOTEX
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	208826	BIONPHARMA INC
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	209284	DR REDDYS
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	204574	HETERO LABS LTD V
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	210544	LUPIN LTD
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	207682	MYLAN
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	213316	PIRAMAL HLTHCARE UK
XENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	Yes	AB	021894	BAUSCH

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