RecallHawk

PREZCOBIX

JANSSEN PRODS

Summary

FDA approved PREZCOBIX by JANSSEN PRODS. NDA (New Drug) approval (Type 3 - New Dosage Form) on 2026-02-27. TABLET, FOR SUSPENSION, ORAL.

Details

Source

Drug Approval

External ID

NDA220092-1

Action Date

2026-02-27

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

PREZCOBIX, TABLET, FOR SUSPENSION, ORAL. Application: NDA220092

Context & Analysis

JANSSEN PRODS has 4 FDA actions in our database.

Frequently Asked Questions

How often does JANSSEN PRODS have FDA actions?

JANSSEN PRODS has 4 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA220092-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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