Details for New Drug Application (NDA): 206288
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The generic ingredient in DARUNAVIR is darunavir. There are twenty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the darunavir profile page.
Summary for 206288
Tradename: | DARUNAVIR |
Applicant: | Cipla |
Ingredient: | darunavir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206288
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 206288
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DARUNAVIR | darunavir | TABLET;ORAL | 206288 | ANDA | Cipla USA Inc. | 69097-244 | 69097-244-02 | 30 TABLET in 1 BOTTLE (69097-244-02) |
DARUNAVIR | darunavir | TABLET;ORAL | 206288 | ANDA | Cipla USA Inc. | 69097-248 | 69097-248-03 | 60 TABLET in 1 BOTTLE (69097-248-03) |
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 |
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