Application 020580
- Type
- BLA
- Sponsor
- ORGANON USA INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 020580 | Cotazym | pancrelipase | 351(a) | Disc | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COTAZYM | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE;ORAL | 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66390 | APPL | 2020-03-23 |