Product NDC: | 42865-105 |
Proprietary Name: | ZENPEP |
Non Proprietary Name: | pancrelipase |
Active Ingredient(s): | 136000; 25000; 85000 [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) |
Product NDC: | 42865-105 |
Labeler Name: | Aptalis Pharma US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022210 |
Marketing Category: | NDA |
Start Marketing Date: | 20110719 |
Package NDC: | 42865-105-01 |
Package Description: | 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (42865-105-01) |
NDC Code | 42865-105-01 |
Proprietary Name | ZENPEP |
Package Description | 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (42865-105-01) |
Product NDC | 42865-105 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | pancrelipase |
Dosage Form Name | CAPSULE, DELAYED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20110719 |
Marketing Category Name | NDA |
Labeler Name | Aptalis Pharma US, Inc. |
Substance Name | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
Strength Number | 136000; 25000; 85000 |
Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
Pharmaceutical Classes |