Application 022523

Type: BLA
Sponsor: VIVUS INC

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

NDC Listings For This Application#

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.	BLA	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 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, 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
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	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 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
62541-402	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, 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 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, 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
62541-404	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 LLC	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, 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
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	BLA	Current
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	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 LLC	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
62541-406	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
62541-406	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE	VIVUS, Inc.	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

Application 022523

Related Records#

Application Products#

NDC Listings For This Application#

Documents#