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Insulin Glargine

These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN. INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is interchangeable* with LANTUS (insulin glargine).

Approved
Approval ID

f8cf3733-952d-4cf1-99ff-5ec7b7247f75

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 30, 2023

Manufacturers
FDA

Mylan Specialty L.P.

DUNS: 194775557

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

insulin glargine-yfgn

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49502-394
Application NumberBLA761201
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin glargine-yfgn
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 15, 2021
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT

insulin glargine-yfgn

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49502-393
Application NumberBLA761201
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin glargine-yfgn
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 15, 2021
FDA Product Classification

INGREDIENTS (8)

POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT

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Insulin Glargine - FDA Drug Approval Details