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FDA Approval

Synjardy

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

FDA Approval Summary

Effective Date
November 13, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Empagliflozin(12.5 mg in 1 1)
Metformin(1000 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Manufacturing Establishments4

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Boehringer Ingelheim Promeco S.A de C.V.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

812579472

Sixarp, LLC

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

016329513

Boehringer Ingelheim Pharma GmbH and Co. KG

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

551147440

West-Ward Columbus Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

058839929

Products4

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

Synjardy

Product Details

NDC Product Code
0597-0168
Application Number
NDA206111
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 13, 2023
Code: HDC1R2M35UClass: ACTIBQuantity: 12.5 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

Synjardy

Product Details

NDC Product Code
0597-0175
Application Number
NDA206111
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 13, 2023
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
Code: HDC1R2M35UClass: ACTIBQuantity: 5 mg in 1 1

Synjardy

Product Details

NDC Product Code
0597-0159
Application Number
NDA206111
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 13, 2023
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
Code: HDC1R2M35UClass: ACTIBQuantity: 5 mg in 1 1

Synjardy

Product Details

NDC Product Code
0597-0180
Application Number
NDA206111
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 13, 2023
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
Code: HDC1R2M35UClass: ACTIBQuantity: 12.5 mg in 1 1
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