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Details for New Drug Application (NDA): 077995

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NDA 077995 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-five 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-six suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for NDA: 077995

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

Pharmacology for NDA: 077995

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 077995

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 077995 ANDA Aidarex Pharmaceuticals LLC 33261-437 33261-437-30 30 TABLET in 1 BOTTLE, PLASTIC (33261-437-30)
TABLET;ORAL 077995 ANDA Aidarex Pharmaceuticals LLC 33261-437 33261-437-60 60 TABLET in 1 BOTTLE, PLASTIC (33261-437-60)

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.