Details for New Drug Application (NDA): 215389
✉ Email this page to a colleague
The generic ingredient in DARUNAVIR is darunavir. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.
Pharmacology for NDA: 215389
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 215389
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DARUNAVIR | darunavir | TABLET;ORAL | 215389 | ANDA | Novadoz Pharmaceuticals LLC | 72205-184 | 72205-184-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-184-60) |
DARUNAVIR | darunavir | TABLET;ORAL | 215389 | ANDA | Novadoz Pharmaceuticals LLC | 72205-185 | 72205-185-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-185-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Nov 28, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Nov 28, 2023 | TE: | AB | RLD: | No |
Complete Access Available with Subscription