Last Updated: May 26, 2026

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. Additional details are available on the PREZCOBIX PED profile page.

The generic ingredient in PREZCOBIX PED is cobicistat; darunavir ethanolate. There are five drug master file entries 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

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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