Drug application
COTAZYM (PANCRELIPASE (AMYLASE, LIPASE, PROTEASE))
Drugs@FDA BLA 020580 · ORGANON USA INC
Key facts
| Drug name | COTAZYM |
|---|---|
| Active ingredients | PANCRELIPASE (AMYLASE, LIPASE, PROTEASE) |
| Application type | BLA |
| Application number | 020580 |
| Company | ORGANON USA INC |
| Dosage forms | CAPSULE, ORAL |
| Strength | 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 7 - Drug Already Marketed without Approved NDA |
| Latest submission status date | Dec 9, 1996 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
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: