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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 206129

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NDA 206129 describes TETRABENAZINE, which is a drug marketed by Actavis Labs Fl Inc, Adaptis, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, and Sun Pharm, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the TETRABENAZINE profile page.

The generic ingredient in TETRABENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.

Summary for 206129

Tradename:	TETRABENAZINE
Applicant:	Sun Pharm
Ingredient:	tetrabenazine
Patents:	0

Pharmacology for NDA: 206129

Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for 206129

Adrenergic Uptake Inhibitors

Suppliers and Packaging for NDA: 206129

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRABENAZINE	tetrabenazine	TABLET;ORAL	206129	ANDA	Sun Pharmaceutical Industries, Inc.	47335-179	47335-179-23	112 TABLET in 1 BOTTLE (47335-179-23)
TETRABENAZINE	tetrabenazine	TABLET;ORAL	206129	ANDA	Sun Pharmaceutical Industries, Inc.	47335-277	47335-277-23	112 TABLET in 1 BOTTLE (47335-277-23)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Aug 17, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 17, 2015	TE:		RLD:	No

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