Drug application
ZENPEP (PANCRELIPASE (AMYLASE, LIPASE, PROTEASE))
Drugs@FDA BLA 022210 · EURAND PHARMA LTD
Key facts
| Drug name | ZENPEP |
|---|---|
| Active ingredients | PANCRELIPASE (AMYLASE, LIPASE, PROTEASE) |
| Application type | BLA |
| Application number | 022210 |
| Company | EURAND PHARMA LTD |
| Dosage forms | CAPSULE, DELAYED RELEASE, ORAL |
| Strength | 24,000USP UNITS;5,000USP UNITS;17,000USP UNITS |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 7 - Drug Already Marketed without Approved NDA |
| Latest submission status date | Aug 27, 2009 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: