ZENPEP - pancrelipase
Navigation: NDC > Supplier starting with: A > APTALIS PHARMA US, INC.| Field | Value |
|---|---|
| NDC Code: | 42865-103 |
| Proprietary Name: | ZENPEP |
| Suffix: | |
| Non-Proprietary Name: | pancrelipase |
| Dosage Form: | CAPSULE, DELAYED RELEASE |
| Method: | ORAL |
| Original Marketing Date: | 22-09-2009 |
| Category Name: | NDA |
| Application Number: | NDA022210 |
| Labeler: | APTALIS PHARMA US, INC. |
| Substance Name: | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
| Active Numerator Strength: | 109000; 20000; 68000 |
| Active Ingredient Unit: | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharm Classes: | |
| DEA Schedule: |