CROSS DISCIPLINE TEAM LEADER REVIEW

Proprietary Name / Established (USAN) names PROTONIX pantoprazole Dosage forms / Strengths NDA 20-020: For Delayed-Release Oral Suspension / 40 mg NDA 20-987: Delayed-Release Tables / 20 mg and 40 mg Proposed Indication Short-term treatment of erosive esophagitis associated with GERD in pediatric patients five years and older Recommended: Approval of NDA 20-987/S036 & S037 and NDA 20-020/S002 for NDA 20-020/S001

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