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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 213621


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NDA 213621 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, Piramal Hlthcare Uk, 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 213621
Tradename:TETRABENAZINE
Applicant:Ajanta Pharma Ltd
Ingredient:tetrabenazine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213621
Medical Subject Heading (MeSH) Categories for 213621
Suppliers and Packaging for NDA: 213621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TETRABENAZINE tetrabenazine TABLET;ORAL 213621 ANDA Ajanta Pharma USA Inc. 27241-176 27241-176-13 112 TABLET in 1 BOTTLE (27241-176-13)
TETRABENAZINE tetrabenazine TABLET;ORAL 213621 ANDA Ajanta Pharma USA Inc. 27241-177 27241-177-13 112 TABLET in 1 BOTTLE (27241-177-13)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Dec 4, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Dec 4, 2020TE:RLD:No

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