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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Healthtrust
Harvard Business School
Julphar
Medtronic
Accenture
Baxter
Johnson and Johnson
Daiichi Sankyo

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020498

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NDA 020498 describes CASODEX, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the CASODEX profile page.

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

Summary for 020498

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020498

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 020498

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CASODEX bicalutamide TABLET;ORAL 020498 NDA AstraZeneca Pharmaceuticals LP 0310-0705 0310-0705-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-0705-30)
CASODEX bicalutamide TABLET;ORAL 020498 NDA Physicians Total Care, Inc. 54868-4503 54868-4503-0 30 TABLET in 1 BOTTLE, PLASTIC (54868-4503-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 4, 1995TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020498

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PharmsCASODEXbicalutamideTABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca PharmsCASODEXbicalutamideTABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca PharmsCASODEXbicalutamideTABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca PharmsCASODEXbicalutamideTABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca PharmsCASODEXbicalutamideTABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Baxter
Teva
McKinsey
UBS
Fish and Richardson
Accenture
Merck
Dow
Medtronic
Deloitte

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.

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