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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209284

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NDA 209284 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 209284

Tradename:	TETRABENAZINE
Applicant:	Dr Reddys
Ingredient:	tetrabenazine
Patents:	0

Pharmacology for NDA: 209284

Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for 209284

Adrenergic Uptake Inhibitors

Suppliers and Packaging for NDA: 209284

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TETRABENAZINE	tetrabenazine	TABLET;ORAL	209284	ANDA	Dr. Reddys Laboratories Inc	43598-394	43598-394-05	500 TABLET in 1 BOTTLE (43598-394-05)
TETRABENAZINE	tetrabenazine	TABLET;ORAL	209284	ANDA	Dr. Reddys Laboratories Inc	43598-394	43598-394-67	112 TABLET in 1 BOTTLE (43598-394-67)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Jan 8, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 8, 2018	TE:	AB	RLD:	No

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