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Serving 500+ biopharmaceutical companies globally:

Express Scripts
McKinsey
Farmers Insurance
US Department of Justice
Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School
QuintilesIMS
Chubb
Teva

Generated: August 23, 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-two suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for NDA: 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 Pharms
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca Pharms
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca Pharms
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca Pharms
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca Pharms
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Cipla
Federal Trade Commission
Dow
AstraZeneca
UBS
Citi
QuintilesIMS
US Army
Chubb

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