| Form
| Dosage
| Status
| Therapeutic Equivalence
| Active Ingred
| Ref.
| Sponsor
| Document
|
| CAPSULE, DELAYED RELEASE; ORAL
| 109,000USP UNITS;20,000USP UNITS;68,000USP UNITS
| Prescription
| (Reference Drug)
| PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
| Pancrelipase
| APTALIS PHARMA US
| 22210
2011-07-14 Medication Guide
2011-07-14 Label
2011-06-17 Letter
2011-06-16 Label
2011-06-15 Letter
2010-06-29 Review
2010-06-29 Summary Review
2009-12-18 Other
2009-09-02 Medication Guide
2009-09-01 Letter
2009-08-27 Label |
| CAPSULE, DELAYED RELEASE; ORAL
| 27,000USP UNITS;5,000USP UNITS;17,000USP UNITS
| Prescription
|
| PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
| Pancrelipase
| APTALIS PHARMA US
| " |
| CAPSULE, DELAYED RELEASE; ORAL
| 55,000USP UNITS;10,000USP UNITS;34,000USP UNITS
| Prescription
|
| PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
| Pancrelipase
| APTALIS PHARMA US
| " |
| CAPSULE, DELAYED RELEASE; ORAL
| 82,000USP UNITS;15,000USP UNITS;51,000USP UNITS
| Prescription
|
| PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
| Pancrelipase
| APTALIS PHARMA US
| " |