| Product NDC: | 17856-1212 |
| Proprietary Name: | Creon |
| Non Proprietary Name: | Pancrelipase |
| Active Ingredient(s): | 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1 & nbsp; Pancrelipase |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, DELAYED RELEASE PELLETS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 17856-1212 |
| Labeler Name: | Atlantic Biologicals Corps |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020725 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100813 |
| Package NDC: | 17856-1212-1 |
| Package Description: | 1 CAPSULE, DELAYED RELEASE PELLETS in 1 POUCH (17856-1212-1) |
| NDC Code | 17856-1212-1 |
| Proprietary Name | Creon |
| Package Description | 1 CAPSULE, DELAYED RELEASE PELLETS in 1 POUCH (17856-1212-1) |
| Product NDC | 17856-1212 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Pancrelipase |
| Dosage Form Name | CAPSULE, DELAYED RELEASE PELLETS |
| Route Name | ORAL |
| Start Marketing Date | 20100813 |
| Marketing Category Name | NDA |
| Labeler Name | Atlantic Biologicals Corps |
| Substance Name | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
| Strength Number | 60000; 12000; 38000 |
| Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharmaceutical Classes |