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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204574

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NDA 204574 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 204574

Tradename:	TETRABENAZINE
Applicant:	Hetero Labs Ltd V
Ingredient:	tetrabenazine
Patents:	0

Pharmacology for NDA: 204574

Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for 204574

Adrenergic Uptake Inhibitors

Suppliers and Packaging for NDA: 204574

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRABENAZINE	tetrabenazine	TABLET;ORAL	204574	ANDA	Camber Pharmaceuticals, Inc.	31722-821	31722-821-11	112 TABLET, COATED in 1 BOTTLE (31722-821-11)
TETRABENAZINE	tetrabenazine	TABLET;ORAL	204574	ANDA	Camber Pharmaceuticals, Inc.	31722-821	31722-821-31	10 TABLET, COATED in 1 BLISTER PACK (31722-821-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Feb 3, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Feb 3, 2016	TE:	AB	RLD:	No

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