Product NDC: | 50458-342 |
Proprietary Name: | PANCREAZE |
Non Proprietary Name: | PANCRELIPASE |
Active Ingredient(s): | 10500; 25000; 43750 [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: | 50458-342 |
Labeler Name: | Janssen Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022523 |
Marketing Category: | NDA |
Start Marketing Date: | 20100412 |
Package NDC: | 50458-342-60 |
Package Description: | 1 BOTTLE, GLASS in 1 CARTON (50458-342-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS |
NDC Code | 50458-342-60 |
Proprietary Name | PANCREAZE |
Package Description | 1 BOTTLE, GLASS in 1 CARTON (50458-342-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS |
Product NDC | 50458-342 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PANCRELIPASE |
Dosage Form Name | CAPSULE, DELAYED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20100412 |
Marketing Category Name | NDA |
Labeler Name | Janssen Pharmaceuticals, Inc. |
Substance Name | PANCRELIPASE; PANCRELIPASE; PANCRELIPASE |
Strength Number | 10500; 25000; 43750 |
Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
Pharmaceutical Classes |