FdaApplication
BLA 022175
Identifiers
- fda_app_no: BLA022175
Properties
| Property | Value |
|---|---|
| applicant_name | Digestive Care, Inc. |
| application_type | BLA |
| approval_date | 2012-05-17 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PERTZYE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS | Capsule, Delayed Release |
| PERTZYE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS | Capsule, Delayed Release |
| PERTZYE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS | Capsule, Delayed Release |
| PERTZYE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS | Capsule, Delayed Release |
4 products