FdaApplication
BLA 022523
Identifiers
- fda_app_no: BLA022523
Properties
| Property | Value |
|---|---|
| applicant_name | VIVUS LLC |
| application_type | BLA |
| approval_date | 2010-04-12 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PANCREAZE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 61,500USP UNITS;10,500USP UNITS;35,500USP UNITS | Capsule, Delayed Release |
| PANCREAZE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 98,400USP UNITS;16,800USP UNITS;56,800USP UNITS | Capsule, Delayed Release |
| PANCREAZE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 149,900USP UNITS;37,000USP UNITS;97,300USP UNITS | Capsule, Delayed Release |
| PANCREAZE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 83,900USP UNITS;21,000USP UNITS;54,700USP UNITS | Capsule, Delayed Release |
| PANCREAZE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 24,600USP UNITS;4,200USP UNITS;14,200USP UNITS | Capsule, Delayed Release |
| PANCREAZE | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | 15,200USP UNITS;2,600USP UNITS;8,800USP UNITS | Capsule, Delayed Release |
6 products