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ULTRESA
ULTRESA - 58914-005-10 - (Pancrelipase)
Drug Information of ULTRESA
| Product NDC: | 58914-005 |
| Proprietary Name: | ULTRESA |
| Non Proprietary Name: | Pancrelipase |
| Active Ingredient(s): | 46000; 23000; 46000 [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) |
Labeler Information of ULTRESA
| Product NDC: | 58914-005 |
| Labeler Name: | Aptalis Pharma US, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022222 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120301 |
Package Information of ULTRESA
| Package NDC: | 58914-005-10 |
| Package Description: | 1 BOTTLE in 1 CARTON (58914-005-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
NDC Information of ULTRESA
| NDC Code | 58914-005-10 |
| Proprietary Name | ULTRESA |
| Package Description | 1 BOTTLE in 1 CARTON (58914-005-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| Product NDC | 58914-005 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Pancrelipase |
| Dosage Form Name | CAPSULE, DELAYED RELEASE |
| 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 | 46000; 23000; 46000 |
| Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharmaceutical Classes |
