Viokace - 58914-117-10 - (Pancrelipase)

Alphabetical Index


Drug Information of Viokace

Product NDC: 58914-117
Proprietary Name: Viokace
Non Proprietary Name: Pancrelipase
Active Ingredient(s): 78300; 20880; 78300    [USP'U]/1; [USP'U]/1; [USP'U]/1 & nbsp;   Pancrelipase
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Viokace

Product NDC: 58914-117
Labeler Name: Aptalis Pharma US, Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022542
Marketing Category: NDA
Start Marketing Date: 20120301

Package Information of Viokace

Package NDC: 58914-117-10
Package Description: 1 BOTTLE in 1 CARTON (58914-117-10) > 100 TABLET in 1 BOTTLE

NDC Information of Viokace

NDC Code 58914-117-10
Proprietary Name Viokace
Package Description 1 BOTTLE in 1 CARTON (58914-117-10) > 100 TABLET in 1 BOTTLE
Product NDC 58914-117
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Pancrelipase
Dosage Form Name TABLET
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 78300; 20880; 78300
Strength Unit [USP'U]/1; [USP'U]/1; [USP'U]/1
Pharmaceutical Classes

Complete Information of Viokace


General Information