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Last Updated: June 12, 2021

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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, Ajanta Pharma Ltd, Apotex, Bionpharma Inc, Dr Reddys, Hetero Labs Ltd V, Hikma, Lupin Ltd, Mylan, Piramal Hlthcare Uk, 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
Applicant:Hetero Labs Ltd V
Formulation / Manufacturing:see details
Pharmacology for NDA: 204574
Medical Subject Heading (MeSH) Categories for 204574
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:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Feb 3, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 3, 2016TE:ABRLD:No

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