Details for New Drug Application (NDA): 216168
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NDA 216168 describes DARUNAVIR, which is a drug marketed by Amneal, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Teva Pharms Usa, and Zydus Lifesciences, and is included in eleven NDAs. It is available from thirteen suppliers. Additional details are available on the DARUNAVIR profile page.
The generic ingredient in DARUNAVIR is darunavir. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.
The generic ingredient in DARUNAVIR is darunavir. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.
Summary for 216168
| Tradename: | DARUNAVIR |
| Applicant: | Annora Pharma |
| Ingredient: | darunavir |
| Patents: | 0 |
Pharmacology for NDA: 216168
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 216168
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARUNAVIR | darunavir | TABLET;ORAL | 216168 | ANDA | Camber Pharmaceuticals, Inc. | 31722-088 | 31722-088-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-088-60) |
| DARUNAVIR | darunavir | TABLET;ORAL | 216168 | ANDA | Camber Pharmaceuticals, Inc. | 31722-089 | 31722-089-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jan 21, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Jan 21, 2025 | TE: | AB | RLD: | No | ||||
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