Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078917

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NDA 078917 describes BICALUTAMIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Fresenius Kabi Usa, Kenton, Kudco Ireland, Mylan, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 078917
Tradename:BICALUTAMIDE
Applicant:Accord Hlthcare
Ingredient:bicalutamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078917
Mechanism of ActionAndrogen Receptor Antagonists
Suppliers and Packaging for NDA: 078917
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE bicalutamide TABLET;ORAL 078917 ANDA Major Pharmaceuticals 0904-6019 0904-6019-46 30 TABLET in 1 BOTTLE (0904-6019-46)
BICALUTAMIDE bicalutamide TABLET;ORAL 078917 ANDA Northstar RxLLC 16714-816 16714-816-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-816-01)

Profile for product number 001

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

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