Application 022523

Type: BLA
Sponsor: VIVUS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
022523	Pancreaze	pancrelipase	351(a)	Rx	2026-06-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS	No	No
002	PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS	No	No
003	PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS	No	No
004	PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS	No	No
005	PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	10,850USP UNITS;2,600USP UNITS;6,200USP UNITS	No	No
006	PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	15,200USP UNITS; 2,600USP UNITS; 8,800USP UNITS	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE	VIVUS LLC	e8f5d2fe-728d-42af-99a6-83dddc6539c5	2025-06-06	Warnings, Adverse reactions	Exact identifier application number: BLA022523 ndc (product): 62541-402 ndc (product): 62541-406 ndc (product): 62541-401 ndc (product): 62541-403 ndc (product): 62541-405 ndc (product): 62541-404

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-341	PANCREAZE	PANCRELIPASE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-342	PANCREAZE	PANCRELIPASE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-343	PANCREAZE	PANCRELIPASE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-346	PANCREAZE	PANCRELIPASE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-347	PANCREAZE	PANCRELIPASE	Janssen Pharmaceuticals, Inc.	NDA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	NDA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-406	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-406	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-406	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-406	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current
62541-406	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS LLC	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77665	SUPPL	2024-02-29
77664	SUPPL	2024-02-29
77656	SUPPL	2024-02-29
69561	SUPPL	2021-12-15
69221	SUPPL	2021-11-03
69216	SUPPL	2021-11-03
62348	SUPPL	2020-03-26
62347	SUPPL	2020-03-26
66391	APPL	2020-03-23
62263	SUPPL	2020-03-23
62231	SUPPL	2020-03-23
62230	SUPPL	2020-03-23
53367	ORIG	2020-03-23
51454	ORIG	2020-03-23
42549	ORIG	2020-03-23
29826	SUPPL	2020-03-23
29825	ORIG	2020-03-23
24331	ORIG	2020-03-23
23411	ORIG	2020-03-23
17678	SUPPL	2020-03-23
17677	SUPPL	2020-03-23
17676	ORIG	2020-03-23
7497	SUPPL	2020-03-23
63543	ORIG	1900-01-01
63542	ORIG	1900-01-01
63541	ORIG	1900-01-01
63230	SUPPL	1900-01-01