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Last Updated: June 9, 2023

Details for New Drug Application (NDA): 020169

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NDA 020169 describes NILANDRON, which is a drug marketed by Concordia and is included in one NDA. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the nilutamide profile page.
Summary for 020169
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
NILANDRON nilutamide TABLET;ORAL 020169 NDA Concordia Pharmaceuticals Inc. 59212-111 59212-111-14 3 BLISTER PACK in 1 CARTON (59212-111-14) / 10 TABLET in 1 BLISTER PACK
NILANDRON nilutamide TABLET;ORAL 020169 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-212 66993-212-38 3 BLISTER PACK in 1 CARTON (66993-212-38) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

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