Application 022175
- Type
- BLA
- Sponsor
- DIGESTIVE CARE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PERTZYE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS | No | No |
| 002 | PERTZYE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 60,500USP UNITS;16,000USP UNITS;57,500USP UNITS | No | No |
| 003 | PERTZYE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 15,125USP UNITS;4,000USP UNITS;14,375USP UNITS | No | No |
| 004 | PERTZYE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 90,750USP UNITS;24,000USP UNITS;86,250USP UNITS | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59767-004 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-004 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-004 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-004 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-004 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-004 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-008 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-008 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-008 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-008 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-008 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-008 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-016 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-016 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-016 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-016 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-016 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-016 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-024 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-024 | PERTZYE | pancrelipase | Digestive Care, Inc. | NDA | Current |
| 59767-024 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-024 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-024 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |
| 59767-024 | PERTZYE | pancrelipase | Digestive Care, Inc. | BLA | Current |