REZVOGLAR KWIKPEN
These highlights do not include all the information needed to use REZVOGLAR safely and effectively. See full prescribing information for REZVOGLAR.REZVOGLAR (insulin glargine-aglr) injection, for subcutaneous useInitial U.S. Approval: 2021REZVOGLAR (insulin glargine-aglr) is interchangeable with LANTUS (insulin glargine)
Approved
Approval ID
78888c87-7155-4e81-954d-cb40822ee27b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Insulin glargine-aglr
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6439
Application NumberBLA761215
Product Classification
M
Marketing Category
C73585
G
Generic Name
Insulin glargine-aglr
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (7)
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
GlycerinInactive
Quantity: 17 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ZincInactive
Quantity: 0.03 mg in 1 mL
Code: J41CSQ7QDS
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
MetacresolInactive
Quantity: 2.7 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT