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Generated: April 30, 2017

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Details for New Drug Application (NDA): 078575

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NDA 078575 describes BICALUTAMIDE, which is a drug marketed by Sun Pharma Global, Stason Pharms, Accord Hlthcare, Teva, Actavis Totowa, Fresenius Kabi Oncol, Synthon Pharms, Apotex Inc, Sandoz, Mylan, Roxane, Zydus Pharms Usa Inc, and Kudco Ireland, and is included in thirteen NDAs. It is available from twenty-three suppliers. Additional details are available on the BICALUTAMIDE profile page.

The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for NDA: 078575

Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 078575

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 078575

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078575 ANDA Sandoz Inc 0781-5409 0781-5409-01 100 TABLET in 1 BOTTLE (0781-5409-01)
TABLET;ORAL 078575 ANDA Sandoz Inc 0781-5409 0781-5409-31 30 TABLET in 1 BOTTLE (0781-5409-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 6, 2009TE:ABRLD:No

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