Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Pharmaceuticals Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.
005286822
Sixarp, LLC
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.
016329513
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Synjardy XR
Product Details
NDC Product Code
0597-0290Application Number
NDA208658Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023EmpagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 5 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
Synjardy XR
Product Details
NDC Product Code
0597-0280Application Number
NDA208658Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
EmpagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 10 mg in 1 1
Synjardy XR
Product Details
NDC Product Code
0597-0295Application Number
NDA208658Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023EmpagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 25 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
Synjardy XR
Product Details
NDC Product Code
0597-0300Application Number
NDA208658Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023EmpagliflozinActive
Code: HDC1R2M35UClass: ACTIBQuantity: 12.5 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1