Details for New Drug Application (NDA): 202895
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The generic ingredient in PREZISTA 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 202895
Tradename: | PREZISTA |
Applicant: | Janssen Prods |
Ingredient: | darunavir |
Patents: | 2 |
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: | ⤷ Sign Up | Patent Expiration: | Jun 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 16, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 202895
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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