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Generated: November 13, 2018

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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. Fifteen 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
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 ANI Pharmaceuticals, Inc. 62559-680 62559-680-30 30 TABLET in 1 BOTTLE (62559-680-30)

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

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