FDA.reportPublic FDA data

Humulin N Purple Book BLA 018781

BLA number
018781
Proprietary names
Humulin N
Proper names
insulin isophane human
Applicant
Eli Lilly and Company
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Humulin Ninsulin isophane human351(a)1,000UNITS/10ML (100UNITS/ML)Injectable SuspensionSubcutaneousMulti-Dose VialOTCLicensed1982-10-28
002Humulin Ninsulin isophane human351(a)300UNITS/3ML (100UNITS/ML)Injectable SuspensionSubcutaneousMulti-Dose VialOTCLicensed1982-10-28
003Humulin Ninsulin isophane human351(a)300UNITS/3ML (100UNITS/ML)Injectable SuspensionSubcutaneousAutoinjectorOTCLicensed2013-11-07

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2021-07-01U003Humulin N351(a)OTCEli Lilly and Company
2020-05-01R001Humulin N351(a)OTCEli Lilly and Company
2020-05-01R002Humulin N351(a)OTCEli Lilly and Company
2020-05-01R003Humulin N351(a)OTCEli Lilly and Company

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Humulin N351(a)OTCLicensed1982-10-28
2020-05-01002Humulin N351(a)OTCLicensed1982-10-28
2020-05-01003Humulin N351(a)OTCLicensed2013-11-07