Details for New Drug Application (NDA): 202083
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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.
Summary for 202083
Tradename: | DARUNAVIR |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | darunavir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202083
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 202083
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DARUNAVIR | darunavir | TABLET;ORAL | 202083 | ANDA | Camber Pharmaceuticals, Inc. | 31722-567 | 31722-567-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-567-60) |
DARUNAVIR | darunavir | TABLET;ORAL | 202083 | ANDA | Camber Pharmaceuticals, Inc. | 31722-568 | 31722-568-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-568-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Sep 14, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Sep 14, 2023 | TE: | AB | RLD: | No |
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