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

Summary for NDA: 020498

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
TABLET;ORAL 020498 NDA AstraZeneca Pharmaceuticals LP 0310-0705 0310-0705-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-0705-30)
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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
TABLET;ORAL020498-001Oct 4, 19951,712,251► subscribe
TABLET;ORAL020498-001Oct 4, 19955,389,613► subscribe
TABLET;ORAL020498-001Oct 4, 19955,712,251► subscribe
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