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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213316

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NDA 213316 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 213316

Tradename:	TETRABENAZINE
Applicant:	Adaptis
Ingredient:	tetrabenazine
Patents:	0

Pharmacology for NDA: 213316

Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for 213316

Adrenergic Uptake Inhibitors

Suppliers and Packaging for NDA: 213316

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRABENAZINE	tetrabenazine	TABLET;ORAL	213316	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-938	23155-938-63	112 TABLET in 1 BOTTLE (23155-938-63)
TETRABENAZINE	tetrabenazine	TABLET;ORAL	213316	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-939	23155-939-63	112 TABLET in 1 BOTTLE (23155-939-63)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Jan 22, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 22, 2020	TE:	AB	RLD:	No

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