FDA.reportPublic FDA data

Application 125559

Type
BLA
Sponsor
SANOFI AVENTIS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125559Praluentalirocumab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRALUENTALIROCUMABINJECTABLE;INJECTION75MGYesNo
002PRALUENTALIROCUMABINJECTABLE;INJECTION150MGYesNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PraluentALIROCUMABRegeneron Pharmaceuticals, Inc.7bcfbac2-e8ac-4569-8edc-bcde3b1fd1722026-07-16Warnings, Adverse reactionsExact identifier
application number: BLA125559
ndc (product): 61755-021
ndc (product): 61755-020
PraluentALIROCUMABSanofi-Aventis U.S. LLC446f6b5c-0dd4-44ff-9bc2-c2b41f2806b42026-07-07Warnings, Adverse reactionsExact identifier
application number: BLA125559
ndc (product): 0024-5903
ndc (product): 0024-5901
ndc (product): 0024-5904
ndc (product): 0024-5902

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 80 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5901PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5902PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5903PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
0024-5904PraluentalirocumabSanofi-Aventis U.S. LLCBLACurrent
61755-020PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-020PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-020PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-020PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-020PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-021PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-021PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-021PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-021PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
61755-021PraluentalirocumabRegeneron Pharmaceuticals, Inc.BLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5901PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent
72733-5902PraluentalirocumabSanofi US CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83852SUPPL 2025-10-21
83770SUPPL 2025-10-15
77774SUPPL 2024-03-11
77772SUPPL 2024-03-08
66986SUPPL2021-04-02
66985SUPPL2021-04-02
66973SUPPL2021-04-02
66972SUPPL2021-04-02
62127SUPPL2020-03-11
62113SUPPL2020-03-11
58473SUPPL2019-04-30
58472SUPPL2019-04-30
58464SUPPL2019-04-29
58463SUPPL2019-04-29
57158SUPPL2019-01-09
56468SUPPL2018-11-15
56381SUPPL2018-11-08
55315SUPPL2018-08-24
55278SUPPL2018-08-23
55035SUPPL2018-07-30
49837SUPPL2017-09-22
49819SUPPL2017-09-21
49646SUPPL2017-08-31
49179SUPPL2017-08-02
48138SUPPL2017-04-27
48099SUPPL2017-04-25
22824ORIG2015-08-28
31997ORIG2015-07-27
18937ORIG2015-07-24