FDA.reportPublic FDA data

Application 210605

Type
BLA
Sponsor
MYLAN PHARMS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
210605Semgleeinsulin glargine351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEMGLEEINSULIN GLARGINEINJECTABLE;INJECTION100 UNITS/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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BASAGLAR KwikPenINSULIN GLARGINEEli Lilly and Company0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae2026-06-16Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
Lantus SolostarINSULIN GLARGINEsanofi-aventis U.S. LLCd5e07a0c-7e14-4756-9152-9fea485d654a2025-06-02Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
TOUJEOINSULIN GLARGINESanofi-Aventis U.S. LLCc9561d96-124d-48ca-982f-0aa1575bff362025-05-30Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
Insulin glargine U-300 MaxINSULIN GLARGINESanofi-Aventis U.S. LLC99ea856d-9562-443a-9422-1006a3cff2f42025-05-30Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
SEMGLEEINSULIN GLARGINE-YFGNBiocon Biologics Inc.8cf5544f-87d6-468b-f6ae-898b1fdb5d802025-03-03Warnings, Adverse reactionsName fallback
brand name: SEMGLEE
Insulin Glargine SolostarINSULIN GLARGINEA-S Medication Solutions9835904f-64f5-42b3-9ac9-89e4aaa5182a2023-11-01Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
LANTUS SOLOSTARINSULIN GLARGINEA-S Medication Solutions3a97c40f-0c83-42d7-a8ee-484b208db4e32023-07-22Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
TOUJEO MaxINSULIN GLARGINEA-S Medication Solutions620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab92023-07-12Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
Lantus SolostarINSULIN GLARGINEA-S Medication Solutions632d9f68-f184-43d5-b184-a3af23f12ad92023-06-06Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
TOUJEOINSULIN GLARGINEA-S Medication Solutions257ca17b-6ff7-4f2e-9037-4c185bac57682023-04-27Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE
LantusINSULIN GLARGINEA-S Medication Solutionsae27bb66-5dbe-4f01-a89e-f4fa7cb09c992023-02-04Warnings, Adverse reactionsName fallback
generic name: INSULIN GLARGINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49502-195SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-195SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-195SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-195SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-196SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-196SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-196SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
49502-196SEMGLEEinsulin glargineMylan Specialty L.P.BLACurrent
50090-5835SEMGLEEinsulin glargineA-S Medication SolutionsBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65661ORIG2020-12-21
63490ORIG2020-06-12
63485APPL2020-06-11
63484ORIG2020-06-11