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Details for New Drug Application (NDA): 077973

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NDA 077973 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-four 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-five suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for NDA: 077973

Tradename:
BICALUTAMIDE
Applicant:
Synthon Pharms
Ingredient:
bicalutamide
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 077973

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 077973

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE
bicalutamide
TABLET;ORAL 077973 ANDA Breckenridge Pharmaceutical, Inc. 51991-560 51991-560-01 100 TABLET, FILM COATED in 1 BOTTLE (51991-560-01)
BICALUTAMIDE
bicalutamide
TABLET;ORAL 077973 ANDA Golden State Medical Supply, Inc. 60429-226 60429-226-05 500 TABLET, FILM COATED in 1 BOTTLE (60429-226-05)

Summary for product number 001

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


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