Drugs@FDA document

OFIRMEV Pediatric Amendment 2 · NDA 022450 SUPPL-10

Drugs@FDA document · MALLINCKRODT HOSP · Dec 8, 2011

Key facts

Drug name OFIRMEV
Document type Pediatric Amendment 2
Application NDA022450
Submission SUPPL-10
Company MALLINCKRODT HOSP
Document date Dec 8, 2011
FDA document accessdata.fda.gov

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  • Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert Document categories
  • 10–99 Documents for this application
  • 1–9 USP chapters cited in this application's documents

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