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FDA BLA · BLA022175

PERTZYE

pancrelipase

Sponsor: DIGESTIVE CARE INC

APPLICATION
BLA022175
TYPE
BLA
ORIGINAL APPROVAL
2012-05-17
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PERTZYEPrescription
PANCRELIPASE (AMYLASE 90,750USP UNITS, LIPASE 24,000USP UNITS, PROTEASE) 86,250USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PERTZYEPrescription
PANCRELIPASE (AMYLASE 60,500USP UNITS, LIPASE 16,000USP UNITS, PROTEASE) 57,500USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PERTZYEPrescription
PANCRELIPASE (AMYLASE 15,125USP UNITS, LIPASE 4,000USP UNITS, PROTEASE) 14,375USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PERTZYEPrescription
PANCRELIPASE (AMYLASE 30,250USP UNITS, LIPASE 8,000USP UNITS, PROTEASE) 28,750USP UNITS · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-02-28Labeling · Supplement 10 · standard — Letter ↗AP
2022-09-28Labeling · Supplement 8 · standard — Letter ↗AP
2020-03-20Labeling · Supplement 6 · standard — Label ↗AP
2017-07-12Labeling · Supplement 4 · standard — Label ↗AP
2016-10-06Manufacturing (CMC) · Supplement 3 · unknown — Pediatric Medical Review ↗AP
2014-01-23Manufacturing (CMC) · Supplement 1 · standardAP
2012-05-17Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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