Drug application
PERTZYE (PANCRELIPASE (AMYLASE, LIPASE, PROTEASE))
Drugs@FDA BLA 022175 · DIGESTIVE CARE INC
Key facts
| Drug name | PERTZYE |
|---|---|
| Active ingredients | PANCRELIPASE (AMYLASE, LIPASE, PROTEASE) |
| Application type | BLA |
| Application number | 022175 |
| Company | DIGESTIVE CARE INC |
| Dosage forms | CAPSULE, DELAYED RELEASE, ORAL |
| Strength | 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 7 - Drug Already Marketed without Approved NDA |
| Latest submission status date | May 17, 2012 |
At a glance
- 1–9 Submissions
- 1–9 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: