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ULTRESA - Pancrelipase

Navigation: NDC > Supplier starting with: A > APTALIS PHARMA US, INC
Field Value
NDC Code: 58914-005
Proprietary Name: ULTRESA
Suffix:
Non-Proprietary Name: Pancrelipase
Dosage Form: CAPSULE, DELAYED RELEASE
Method: ORAL
Original Marketing Date: 01-03-2012
Category Name: NDA
Application Number: NDA022222
Labeler: APTALIS PHARMA US, INC
Substance Name: PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active Numerator Strength: 46000; 23000; 46000
Active Ingredient Unit: [USP'U]/1; [USP'U]/1; [USP'U]/1
Pharm Classes:
DEA Schedule: