FDA.reportPublic FDA data

Application 020563

Type
BLA
Sponsor
LILLY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020563Humaloginsulin lispro351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMALOGINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLNoNo
002HUMALOG PENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLNoNo
003HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLNoNo
004HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION200UNITS/MLNoNo
005HUMALOG TEMPO PENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100UNITS/MLNoNo

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-01-09Warnings, Adverse reactionsExact identifier
application number: BLA020563
Insulin LisproINSULIN LISPROEli Lilly and Company97d5e596-aae1-42c9-ae89-c3780959c4672025-06-17Warnings, Adverse reactionsExact identifier
application number: BLA020563
HUMALOGINSULIN LISPROA-S Medication Solutionsc6b8ff07-d3e2-457f-8a38-b60de60adf752025-04-01Warnings, Adverse reactionsExact identifier
application number: BLA020563
Insulin LisproINSULIN LISPROA-S Medication Solutions2be14cbb-197a-4da8-82c8-2443594e7f6f2024-05-31Warnings, Adverse reactionsExact identifier
application number: BLA020563
HUMALOGINSULIN LISPROA-S Medication Solutions6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c2024-02-15Warnings, Adverse reactionsExact identifier
application number: BLA020563
Humalog KwikPenINSULIN LISPROA-S Medication Solutions51d3dc11-52b9-4296-a2f4-58c770d4448d2024-01-24Warnings, Adverse reactionsExact identifier
application number: BLA020563

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1389HumalogInsulin lisproREMEDYREPACK INC.NDACurrent
70518-1389HumalogInsulin lisproREMEDYREPACK INC.BLACurrent
70518-1389HumalogInsulin lisproREMEDYREPACK INC.BLACurrent
70518-2264HumalogInsulin lisproREMEDYREPACK INC.NDACurrent
70518-2398Insulin lisproInsulin LisproREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2398Insulin lisproInsulin LisproREMEDYREPACK INC.BLACurrent
70518-2398Insulin lisproInsulin LisproREMEDYREPACK INC.BLACurrent
70518-2802Insulin LisproInsulin lisproREMEDYREPACK INC.BLACurrent
70518-2802Insulin LisproInsulin lisproREMEDYREPACK INC.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82184SUPPL 2025-05-14
82258SUPPL 2025-05-07
74876SUPPL 2024-05-28
74870SUPPL 2023-07-24
66376APPL2020-03-23
60923SUPPL2020-03-23
60921SUPPL2020-03-23
60919SUPPL2020-03-23
60864SUPPL2020-03-23
60863SUPPL2020-03-23
60862SUPPL2020-03-23
59698SUPPL2020-03-23
59696SUPPL2020-03-23
57662ORIG2020-03-23
57206SUPPL2020-03-23
56840SUPPL2020-03-23
56715SUPPL2020-03-23
56293SUPPL2020-03-23
56247SUPPL2020-03-23
48670SUPPL2020-03-23
48665SUPPL2020-03-23
46791SUPPL2020-03-23
46765SUPPL2020-03-23
41434SUPPL2020-03-23
41433SUPPL2020-03-23
34852SUPPL2020-03-23
34851SUPPL2020-03-23
34850SUPPL2020-03-23
34849SUPPL2020-03-23
34848SUPPL2020-03-23
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34846SUPPL2020-03-23
34845SUPPL2020-03-23
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34843SUPPL2020-03-23
34842SUPPL2020-03-23
34841SUPPL2020-03-23
34840SUPPL2020-03-23
34839SUPPL2020-03-23
25195SUPPL2020-03-23
25194SUPPL2020-03-23
25193SUPPL2020-03-23
25192SUPPL2020-03-23
25191SUPPL2020-03-23
25190SUPPL2020-03-23
25189SUPPL2020-03-23
25188SUPPL2020-03-23
25187SUPPL2020-03-23
25186SUPPL2020-03-23
25185SUPPL2020-03-23
25184SUPPL2020-03-23
12744SUPPL2020-03-23
12743SUPPL2020-03-23
12742SUPPL2020-03-23
12741SUPPL2020-03-23
12740SUPPL2020-03-23
12739SUPPL2020-03-23
12738SUPPL2020-03-23
12737SUPPL2020-03-23
12736SUPPL2020-03-23
12735SUPPL2020-03-23
12734SUPPL2020-03-23
12733SUPPL2020-03-23
12732SUPPL2020-03-23
12731SUPPL2020-03-23
2747SUPPL2020-03-23
2746SUPPL2020-03-23
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2743SUPPL2020-03-23
2742SUPPL2020-03-23
2741SUPPL2020-03-23
2740SUPPL2020-03-23
2739SUPPL2020-03-23
2738SUPPL2020-03-23
2737SUPPL2020-03-23
2736SUPPL2020-03-23
2735SUPPL2020-03-23
2734SUPPL2020-03-23
2733SUPPL2020-03-23
2732SUPPL2020-03-23