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Baxter
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Medtronic
Moodys
Colorcon
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Julphar
Cantor Fitzgerald
Merck

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020498

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NDA 020498 describes CASODEX, which is a drug marketed by Ani Pharms Inc 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. Eighteen suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 020498
Tradename:CASODEX
Applicant:Ani Pharms Inc
Ingredient:bicalutamide
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 N 0310-0705-30
CASODEX bicalutamide TABLET;ORAL 020498 NDA Physicians Total Care, Inc. 54868-4503 E 54868-4503-0

Profile for product number 001

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

Expired US Patents for NDA 020498

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc CASODEX bicalutamide TABLET;ORAL 020498-001 Oct 4, 1995 ➤ Sign Up ➤ Sign Up
Ani Pharms Inc CASODEX bicalutamide TABLET;ORAL 020498-001 Oct 4, 1995 ➤ Sign Up ➤ Sign Up
Ani Pharms Inc CASODEX bicalutamide TABLET;ORAL 020498-001 Oct 4, 1995 ➤ Sign Up ➤ Sign Up
Ani Pharms Inc CASODEX bicalutamide TABLET;ORAL 020498-001 Oct 4, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
Argus Health
Queensland Health
Fuji
Dow
Deloitte
US Army
Federal Trade Commission

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