Details for New Drug Application (NDA): 202073
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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: 202073
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 202073
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DARUNAVIR | darunavir | TABLET;ORAL | 202073 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-345 | 68180-345-07 | 60 TABLET, FILM COATED in 1 BOTTLE (68180-345-07) |
DARUNAVIR | darunavir | TABLET;ORAL | 202073 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-346 | 68180-346-06 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-346-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Sep 29, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Sep 29, 2022 | TE: | AB | RLD: | No |
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