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ZENPEP - pancrelipase

Navigation: NDC > Supplier starting with: A > APTALIS PHARMA US, INC.
Field Value
NDC Code: 42865-104
Proprietary Name: ZENPEP
Suffix:
Non-Proprietary Name: pancrelipase
Dosage Form: CAPSULE, DELAYED RELEASE
Method: ORAL
Original Marketing Date: 22-09-2009
Category Name: NDA
Application Number: NDA022210
Labeler: APTALIS PHARMA US, INC.
Substance Name: PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active Numerator Strength: 16000; 3000; 10000
Active Ingredient Unit: [USP'U]/1; [USP'U]/1; [USP'U]/1
Pharm Classes:
DEA Schedule: