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.
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
| Tradename: | NILANDRON |
| Applicant: | Concordia |
| Ingredient: | nilutamide |
| Patents: | 0 |
| 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 | 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: | 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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