← FDA DRUG APPROVALS

FDA BLA · BLA022210

ZENPEP

pancrelipase lipase, pancrelipase protease, pancrelipase amylase

Sponsor: EURAND PHARMA LTD

APPLICATION
BLA022210
TYPE
BLA
ORIGINAL APPROVAL
2009-08-27
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ZENPEPPrescription
PANCRELIPASE (AMYLASE 168,000USP UNITS, LIPASE 40,000USP UNITS, PROTEASE) 126,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 14,000USP UNITS, LIPASE 3,000USP UNITS, PROTEASE) 10,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 63,000USP UNITS, LIPASE 15,000USP UNITS, PROTEASE) 47,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 24,000USP UNITS, LIPASE 5,000USP UNITS, PROTEASE) 17,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 252,600USP UNITS, LIPASE 60,000USP UNITS, PROTEASE) 189,600USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 105,000USP UNITS, LIPASE 25,000USP UNITS, PROTEASE) 79,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 84,000USP UNITS, LIPASE 20,000USP UNITS, PROTEASE) 63,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
ZENPEPPrescription
PANCRELIPASE (AMYLASE 42,000USP UNITS, LIPASE 10,000USP UNITS, PROTEASE) 32,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-02-28Labeling · Supplement 26 · standard — Letter ↗AP
2023-10-27Labeling · Supplement 27 · standard — Letter ↗AP
2022-09-28Labeling · Supplement 24 · standard — Label ↗AP
2020-03-20Labeling · Supplement 21 · standard — Label ↗AP
2016-12-19Manufacturing (CMC) · Supplement 17 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 11 · priorityAP
2014-03-25Manufacturing (CMC) · Supplement 16 — Label ↗AP
2013-12-09Manufacturing (CMC) · Supplement 15 · priorityAP
2013-04-11Labeling · Supplement 12 · standard — Label ↗AP
2013-04-11Labeling · Supplement 9 · standard — Letter ↗AP
2011-07-13Manufacturing (CMC) · Supplement 5 — Label ↗AP
2011-06-15Manufacturing (CMC) · Supplement 6 — Pediatric Medical Review ↗AP
2011-06-10REMS · Supplement 8 — Letter ↗AP
2009-08-27Type 7 - Drug Already Marketed without Approved NDA · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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