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Nilutamideis the generic ingredient in two branded drugs marketed by Concordia and Ani Pharms Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.
There are two drug master file entries for nilutamide. Three suppliers are listed for this compound.
Summary for nilutamide
Recent Clinical Trials for nilutamide
Identify potential brand extensions & 505(b)(2) entrants
|Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair||Phase 2/Phase 3|
|PPD||Phase 2/Phase 3|
|Fundação de Amparo à Pesquisa do Estado de São Paulo||Phase 4|
Pharmacology for nilutamide
|Drug Class||Androgen Receptor Inhibitor |
|Mechanism of Action||Androgen Receptor Antagonists |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Concordia||NILANDRON||nilutamide||TABLET;ORAL||020169-002||Apr 30, 1999||AB||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Concordia||NILANDRON||nilutamide||TABLET;ORAL||020169-001||Sep 19, 1996||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Ani Pharms Inc||NILUTAMIDE||nilutamide||TABLET;ORAL||207631-001||Jul 15, 2016||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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