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)Rx2026-08-01

Application Products#

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

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 · 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