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FDA Approval

Jardiance

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Cardinal Health 107, LLC
DUNS: 118546603
Effective Date
January 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
empagliflozin(10 mg in 1 1)
Empagliflozin(10 mg in 1 1)

Products2

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

Jardiance

Product Details

NDC Product Code
55154-0411
Application Number
NDA204629
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 2, 2019
empagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 10 mg in 1 1
EmpagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 10 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

Jardiance

Product Details

NDC Product Code
55154-0412
Application Number
NDA204629
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 2, 2019
empagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 25 mg in 1 1
EmpagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 25 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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Jardiance - FDA Approval | MedPath