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Details for New Drug Application (NDA): 020169

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NDA 020169 describes NILANDRON, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the NILANDRON profile page.

The generic ingredient in NILANDRON is nilutamide. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nilutamide profile page.

Summary for NDA: 020169

Concordia Pharms Inc
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020169

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 020169

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 020169 NDA sanofi-aventis U.S. LLC 0088-1111 0088-1111-14 30 TABLET in 1 BOX (0088-1111-14)
TABLET;ORAL 020169 NDA Covis Pharmaceuticals, Inc. 24987-111 24987-111-14 1 BLISTER PACK in 1 CARTON (24987-111-14) > 30 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Sep 19, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 30, 1999TE:ABRLD:Yes

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