Application 022210

Type: BLA
Sponsor: ZENPEP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
022210	Zenpep	pancrelipase	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	24,000USP UNITS;5,000USP UNITS;17,000USP UNITS	No	No
002	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	42,000USP UNITS;10,000USP UNITS;32,000USP UNITS	No	No
003	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	63,000USP UNITS;15,000USP UNITS;47,000USP UNITS	No	No
004	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	84,000USP UNITS;20,000USP UNITS;63,000USP UNITS	No	No
005	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	14,000USP UNITS;3,000USP UNITS;10,000USP UNITS	No	No
006	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	105,000USP UNITS;25,000USP UNITS;79,000USP UNITS	No	No
007	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	168,000USP UNITS;40,000USP UNITS;126,000USP UNITS	No	No
008	ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	252,600USP UNITS;60,000USP UNITS;189,600USP 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
Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Aimmune Therapeutics, Inc.	7f16f2d4-8df6-4bd7-ac10-56994fa257b0	2025-11-14	Warnings, Adverse reactions	Exact identifier application number: BLA022210 ndc (product): 73562-112 ndc (product): 73562-114 ndc (product): 73562-115 ndc (product): 73562-111 ndc (product): 73562-110 ndc (product): 73562-113 ndc (product): 73562-116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6110	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6110	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6110	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
0023-6111	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6111	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6111	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
0023-6112	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6112	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6112	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
0023-6113	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6113	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6113	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
0023-6114	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6114	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6114	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
0023-6115	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6115	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6115	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
0023-6116	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6116	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	NDA	Current
0023-6116	Zenpep	PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE	Allergan, Inc.	BLA	Current
42865-300	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
42865-302	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
42865-303	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
42865-304	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
42865-305	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
42865-306	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
42865-307	ZENPEP	pancrelipase	Allergan, Inc.	NDA	Current
73562-110	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-110	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-111	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-111	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-112	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-112	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-113	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-113	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-114	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-114	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-115	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-115	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-116	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-116	Zenpep	pancrelipase lipase, pancrelipase protease, pancrelipase amylase	Nestle Healthcare Nutrition, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77671	SUPPL	2024-02-29
77670	SUPPL	2024-02-29
77655	SUPPL	2024-02-29
75984	SUPPL	2023-10-30
72816	SUPPL	2022-12-07
72805	SUPPL	2022-12-07
72804	SUPPL	2022-12-07
72202	SUPPL	2022-09-30
72199	SUPPL	2022-09-30
72179	SUPPL	2022-09-29
66395	APPL	2020-03-23
62225	SUPPL	2020-03-23
62224	SUPPL	2020-03-23
54071	SUPPL	2020-03-23
53377	ORIG	2020-03-23
53376	ORIG	2020-03-23
51460	ORIG	2020-03-23
44703	ORIG	2020-03-23
38389	SUPPL	2020-03-23
38388	SUPPL	2020-03-23
29412	SUPPL	2020-03-23
29411	SUPPL	2020-03-23
29410	SUPPL	2020-03-23
23365	ORIG	2020-03-23
21958	ORIG	2020-03-23
17091	SUPPL	2020-03-23
17090	SUPPL	2020-03-23
17089	SUPPL	2020-03-23
17088	ORIG	2020-03-23
7054	SUPPL	2020-03-23
7053	ORIG	2020-03-23
68847	SUPPL	1900-01-01
67206	SUPPL	1900-01-01
67150	ORIG	1900-01-01