ULTRESA - Pancrelipase
Navigation: NDC > Supplier starting with: A > APTALIS PHARMA US, INC| Field | Value |
|---|---|
| NDC Code: | 58914-005 |
| Proprietary Name: | ULTRESA |
| Suffix: | |
| Non-Proprietary Name: | Pancrelipase |
| Dosage Form: | CAPSULE, DELAYED RELEASE |
| Method: | ORAL |
| Original Marketing Date: | 01-03-2012 |
| Category Name: | NDA |
| Application Number: | NDA022222 |
| Labeler: | APTALIS PHARMA US, INC |
| Substance Name: | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
| Active Numerator Strength: | 46000; 23000; 46000 |
| Active Ingredient Unit: | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharm Classes: | |
| DEA Schedule: |