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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 208826


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NDA 208826 describes TETRABENAZINE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, Slate Run Pharma, 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 are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
Summary for 208826
Tradename:TETRABENAZINE
Applicant:Bionpharma
Ingredient:tetrabenazine
Patents:0
Pharmacology for NDA: 208826
Medical Subject Heading (MeSH) Categories for 208826
Suppliers and Packaging for NDA: 208826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TETRABENAZINE tetrabenazine TABLET;ORAL 208826 ANDA Bionpharma Inc. 69452-117 69452-117-21 112 TABLET in 1 BOTTLE (69452-117-21)
TETRABENAZINE tetrabenazine TABLET;ORAL 208826 ANDA Bionpharma Inc. 69452-118 69452-118-21 112 TABLET in 1 BOTTLE (69452-118-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Dec 18, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 18, 2017TE:ABRLD:No

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