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