Last Updated: September 28, 2026

Details for New Drug Application (NDA): 206686

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NDA 206686 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 ten suppliers. Additional details are available on the TETRABENAZINE profile page.

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

Summary for 206686

Tradename:	TETRABENAZINE
Applicant:	Actavis Labs Fl Inc
Ingredient:	tetrabenazine
Patents:	0

Medical Subject Heading (MeSH) Categories for 206686

Adrenergic Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 7, 2017	TE:	AB	RLD:	No

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