DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 020169
NDA 020169 describes NILANDRON, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from one supplier. 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. Two suppliers are listed for this compound. Additional details are available on the nilutamide profile page.
The generic ingredient in NILANDRON is nilutamide. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nilutamide profile page.
Summary for 020169
| Tradename: | NILANDRON |
| Applicant: | Concordia Pharms Inc |
| Ingredient: | nilutamide |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Suppressant (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020169
| Mechanism of Action | Androgen 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 | N | 59212-111-14 |
| NILANDRON | nilutamide | TABLET;ORAL | 020169 | NDA | Concordia Pharmaceuticals Inc. | 59212-111 | N | 59212-111-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 19, 1996 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 30, 1999 | TE: | AB | RLD: | Yes | ||||
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