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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 Sun Pharma Global, Hetero Labs Ltd V, and Apicore Us, and is included in three NDAs. It is available from four suppliers. Additional details are available on the TETRABENAZINE profile page.

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

Summary for NDA: 204574

Hetero Labs Ltd V
Formulation / Manufacturing:see details

Pharmacology for NDA: 204574

Suppliers and Packaging for NDA: 204574

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 204574 ANDA Camber Pharmaceuticals, Inc. 31722-821 31722-821-11 112 TABLET, COATED in 1 BOTTLE (31722-821-11)
TABLET;ORAL 204574 ANDA Camber Pharmaceuticals, Inc. 31722-821 31722-821-31 10 TABLET, COATED in 1 BLISTER PACK (31722-821-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Feb 3, 2016TE:ABRLD:No

Summary for product number 002

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

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