← FDA DRUG APPROVALS

FDA BLA · BLA022523

PANCREAZE

pancrelipase lipase, pancrelipase amylase, and pancrelipase protease

Sponsor: VIVUS INC

APPLICATION
BLA022523
TYPE
BLA
ORIGINAL APPROVAL
2010-04-12
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PANCREAZEPrescription
PANCRELIPASE (AMYLASE 149,900USP UNITS, LIPASE 37,000USP UNITS, PROTEASE) 97,300USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PANCREAZEPrescription
PANCRELIPASE (AMYLASE 98,400USP UNITS, LIPASE 16,800USP UNITS, PROTEASE) 56,800USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PANCREAZEPrescription
PANCRELIPASE (AMYLASE 24,600USP UNITS, LIPASE 4,200USP UNITS, PROTEASE) 14,200USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PANCREAZEPrescription
PANCRELIPASE (AMYLASE 15,200USP UNITS, LIPASE 2,600USP UNITS, PROTEASE) 8,800USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PANCREAZEPrescription
PANCRELIPASE (AMYLASE 83,900USP UNITS, LIPASE 21,000USP UNITS, PROTEASE) 54,700USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
PANCREAZEPrescription
PANCRELIPASE (AMYLASE 61,500USP UNITS, LIPASE 10,500USP UNITS, PROTEASE) 35,500USP UNITS · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-02-28Labeling · Supplement 19 · standard — Letter ↗AP
2021-04-26Labeling · Supplement 16 · standard — Letter ↗AP
2020-03-20Labeling · Supplement 13 · standard — Other ↗AP
2020-01-28Manufacturing (CMC) · Supplement 14 — Label ↗AP
2016-08-04Manufacturing (CMC) · Supplement 10 · standardAP
2016-05-16Manufacturing (CMC) · Supplement 7 · standardAP
2015-03-30Manufacturing (CMC) · Supplement 9 · standardAP
2015-03-03Manufacturing (CMC) · Supplement 8 · standardAP
2014-06-23Manufacturing (CMC) · Supplement 6 · standardAP
2014-05-27Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP
2014-03-07Manufacturing (CMC) · Supplement 4 · standard — Pediatric Medical Review ↗AP
2012-12-07Manufacturing (CMC) · Supplement 3 · standardAP
2011-06-20REMS · Supplement 2 — Letter ↗AP
2010-04-12Type 7 - Drug Already Marketed without Approved NDA · Original · standard — 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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