Neonatal Respiratory Distress Syndrome
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FDA label_change · 2013-12-23FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
FDA approved a supplemental application for INFASURF (calfactant) by ONY Biotech Inc., likely updating product labeling.
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FDA label_change · 2009-12-10FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
FDA approved a supplemental application for INFASURF (calfactant) submitted by ONY Biotech Inc. The action likely updates the product's labe…