FDA.reportPublic FDA data

Application 022210

Type
BLA
Sponsor
ZENPEP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL24,000USP UNITS;5,000USP UNITS;17,000USP UNITSNoNo
002ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL42,000USP UNITS;10,000USP UNITS;32,000USP UNITSNoNo
003ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL63,000USP UNITS;15,000USP UNITS;47,000USP UNITSNoNo
004ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL84,000USP UNITS;20,000USP UNITS;63,000USP UNITSNoNo
005ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL14,000USP UNITS;3,000USP UNITS;10,000USP UNITSNoNo
006ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL105,000USP UNITS;25,000USP UNITS;79,000USP UNITSNoNo
007ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL168,000USP UNITS;40,000USP UNITS;126,000USP UNITSNoNo
008ZENPEPPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL252,600USP UNITS;60,000USP UNITS;189,600USP UNITSNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6110ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
0023-6110ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6110ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6111ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
0023-6111ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6111ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6112ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6112ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6112ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
0023-6113ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6113ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
0023-6113ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6114ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
0023-6114ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6114ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6115ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6115ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
0023-6115ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6116ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6116ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.NDACurrent
0023-6116ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAllergan, Inc.BLACurrent
42865-300ZENPEPpancrelipaseAllergan, Inc.NDACurrent
42865-302ZENPEPpancrelipaseAllergan, Inc.NDACurrent
42865-303ZENPEPpancrelipaseAllergan, Inc.NDACurrent
42865-304ZENPEPpancrelipaseAllergan, Inc.NDACurrent
42865-305ZENPEPpancrelipaseAllergan, Inc.NDACurrent
42865-306ZENPEPpancrelipaseAllergan, Inc.NDACurrent
42865-307ZENPEPpancrelipaseAllergan, Inc.NDACurrent
73562-110Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-110Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-111Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-111Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-112Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-112Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-113Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-113Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-114Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-114Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-115Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-115Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-116Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-116Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylaseNestle Healthcare Nutrition, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77671SUPPL 2024-02-29
77670SUPPL 2024-02-29
77655SUPPL 2024-02-29
75984SUPPL 2023-10-30
72816SUPPL2022-12-07
72805SUPPL2022-12-07
72804SUPPL2022-12-07
72202SUPPL2022-09-30
72199SUPPL2022-09-30
72179SUPPL2022-09-29
66395APPL2020-03-23
62225SUPPL2020-03-23
62224SUPPL2020-03-23
54071SUPPL2020-03-23
53377ORIG2020-03-23
53376ORIG2020-03-23
51460ORIG2020-03-23
44703ORIG2020-03-23
38389SUPPL2020-03-23
38388SUPPL2020-03-23
29412SUPPL2020-03-23
29411SUPPL2020-03-23
29410SUPPL2020-03-23
23365ORIG2020-03-23
21958ORIG2020-03-23
17091SUPPL2020-03-23
17090SUPPL2020-03-23
17089SUPPL2020-03-23
17088ORIG2020-03-23
7054SUPPL2020-03-23
7053ORIG2020-03-23
68847SUPPL1900-01-01
67206SUPPL1900-01-01
67150ORIG1900-01-01