ULTRESA - 58914-005-10 - (Pancrelipase)

Alphabetical Index


Drug Information of ULTRESA

Product NDC: 58914-005
Proprietary Name: ULTRESA
Non Proprietary Name: Pancrelipase
Active Ingredient(s): 46000; 23000; 46000    [USP'U]/1; [USP'U]/1; [USP'U]/1 & nbsp;   Pancrelipase
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, DELAYED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of ULTRESA

Product NDC: 58914-005
Labeler Name: Aptalis Pharma US, Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022222
Marketing Category: NDA
Start Marketing Date: 20120301

Package Information of ULTRESA

Package NDC: 58914-005-10
Package Description: 1 BOTTLE in 1 CARTON (58914-005-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC Information of ULTRESA

NDC Code 58914-005-10
Proprietary Name ULTRESA
Package Description 1 BOTTLE in 1 CARTON (58914-005-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product NDC 58914-005
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Pancrelipase
Dosage Form Name CAPSULE, DELAYED RELEASE
Route Name ORAL
Start Marketing Date 20120301
Marketing Category Name NDA
Labeler Name Aptalis Pharma US, Inc
Substance Name PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Strength Number 46000; 23000; 46000
Strength Unit [USP'U]/1; [USP'U]/1; [USP'U]/1
Pharmaceutical Classes

Complete Information of ULTRESA


General Information