Details for New Drug Application (NDA): 212493
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NDA 212493 describes DARUNAVIR, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Teva Pharms Usa, and Zydus Lifesciences, and is included in nine NDAs. It is available from twelve suppliers. Additional details are available on the DARUNAVIR profile page.
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.
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: 212493
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 212493
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARUNAVIR | darunavir | TABLET;ORAL | 212493 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1144 | 60219-1144-6 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| DARUNAVIR | darunavir | TABLET;ORAL | 212493 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1145 | 60219-1145-3 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Dec 8, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Dec 8, 2023 | TE: | AB | RLD: | No | ||||
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