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The document is a clinical pharmacology and biopharmaceutics review for the New Drug Application (NDA) 22-523 submitted by Johnson & Johnson for Pancreaze (pancrelipase) capsules. It details the drug's formulation, strengths, indications for treating exocrine pancreatic insufficiency due to conditions like cystic fibrosis and chronic pancreatitis, and summarizes clinical studies supporting its safety and efficacy. The review includes recommendations for labeling, dosing regimens for different age groups, and findings from in vitro compatibility studies with baby foods and infant formula. Overall, it concludes that the application is acceptable pending agreement on package insert language.

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