FdaApplication
BLA 022210
Identifiers
- fda_app_no: BLA022210
Properties
| Property | Value |
|---|---|
| applicant_name | Aimmune Therapeutics, Inc. |
| application_type | BLA |
| approval_date | 2009-08-27 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS | Capsule, Delayed Release |
| ZENPEP | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS | Capsule, Delayed Release |
8 products