Drugs@FDA document

IBTROZI Label · NDA 219713 ORIG-1

Drugs@FDA document · NUVATION · Jun 12, 2025

Key facts

Drug name IBTROZI
Document type Label
Application NDA219713
Submission ORIG-1
Company NUVATION
Document date Jun 12, 2025
FDA document accessdata.fda.gov

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Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date:

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