Details for New Drug Application (NDA): 202895
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NDA 202895 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the PREZISTA profile page.
The generic ingredient in PREZISTA 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 PREZISTA 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 202895
| Tradename: | PREZISTA |
| Applicant: | Janssen Prods |
| Ingredient: | darunavir |
| Patents: | 1 |
Pharmacology for NDA: 202895
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 202895
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREZISTA | darunavir | SUSPENSION;ORAL | 202895 | NDA | Janssen Products LP | 59676-565 | 59676-565-01 | 1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100MG/ML | ||||
| Approval Date: | Dec 16, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 7,700,645*PED | Patent Expiration: | Jun 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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