Details for New Drug Application (NDA): 220092
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NDA 220092 describes PREZCOBIX PED, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. Additional details are available on the PREZCOBIX PED profile page.
The generic ingredient in PREZCOBIX PED is cobicistat; darunavir ethanolate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.
The generic ingredient in PREZCOBIX PED is cobicistat; darunavir ethanolate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.
Summary for 220092
| Tradename: | PREZCOBIX PED |
| Applicant: | Janssen Prods |
| Ingredient: | cobicistat; darunavir ethanolate |
| Patents: | 0 |
Pharmacology for NDA: 220092
Suppliers and Packaging for NDA: 220092
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREZCOBIX PED | cobicistat; darunavir ethanolate | TABLET, FOR SUSPENSION;ORAL | 220092 | NDA | Janssen Products, LP | 59676-577 | 59676-577-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 90MG;EQ 600MG BASE | ||||
| Approval Date: | Feb 27, 2026 | TE: | RLD: | Yes | |||||
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