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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 213621

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NDA 213621 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 213621

Tradename:	TETRABENAZINE
Applicant:	Ajanta Pharma Ltd
Ingredient:	tetrabenazine
Patents:	0

Pharmacology for NDA: 213621

Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for 213621

Adrenergic Uptake Inhibitors

Suppliers and Packaging for NDA: 213621

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRABENAZINE	tetrabenazine	TABLET;ORAL	213621	ANDA	Ajanta Pharma USA Inc.	27241-176	27241-176-13	112 TABLET in 1 BOTTLE (27241-176-13)
TETRABENAZINE	tetrabenazine	TABLET;ORAL	213621	ANDA	Ajanta Pharma USA Inc.	27241-177	27241-177-13	112 TABLET in 1 BOTTLE (27241-177-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Dec 4, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Dec 4, 2020	TE:		RLD:	No

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