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Pancreaze FDA Approval History

FDA Approved: Yes (First approved April 12, 2010)
Brand name: Pancreaze
Generic name: pancrelipase
Dosage form: Delayed-Release Capsules
Company: Ortho-McNeil Pharmaceutical, LLC
Treatment for: Pancreatic Exocrine Dysfunction

Pancreaze (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Development Timeline for Pancreaze

Apr 13, 2010ApprovalFDA Approves Pancreatic Enzyme Product, Pancreaze

Further information

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