Details for New Drug Application (NDA): 210677
✉ 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.
Summary for 210677
Tradename: | DARUNAVIR |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | darunavir |
Patents: | 0 |
Pharmacology for NDA: 210677
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 210677
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DARUNAVIR | darunavir | TABLET;ORAL | 210677 | ANDA | Aurobindo Pharma Limited | 59651-085 | 59651-085-60 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60) |
DARUNAVIR | darunavir | TABLET;ORAL | 210677 | ANDA | Aurobindo Pharma Limited | 59651-086 | 59651-086-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-086-30) |
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