Application 220092

Type: NDA
Sponsor: JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREZCOBIX PED	COBICISTAT; DARUNAVIR ETHANOLATE	TABLET, FOR SUSPENSION;ORAL	90MG;EQ 600MG BASE	Yes	Yes
002	PREZCOBIX	DARUNAVIR AND COBICISTAT	TABLET, FOR SUSPENSION;ORAL	675MG/150MG	No	No
003	PREZCOBIX	DARUNAVIR AND COBICISTAT	TABLET, FOR SUSPENSION;ORAL	600MG/90MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N220092-001	PREZCOBIX PED	COBICISTAT; DARUNAVIR ETHANOLATE	90MG;EQ 600MG BASE	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2026-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N220092-001	PREZCOBIX PED	90MG;EQ 600MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2026-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220092-001	PREZCOBIX PED	90MG;EQ 600MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2026-02-27	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220092-001	PREZCOBIX PED	90MG;EQ 600MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2026-02-27	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREZCOBIX	DARUNAVIR ETHANOLATE AND COBICISTAT	Janssen Products, LP	9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 220092 application number: NDA220092

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85220	ORIG	2026-03-03