Details for New Drug Application (NDA): 020169
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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 |
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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