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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208658

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SYNJARDY XR (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
5MG;1GM
Marketing Status: Prescription
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SYNJARDY XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208658
Product Number: 001
Approval Date: Dec 9, 2016
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SYNJARDY XR (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
10MG;1GM
Marketing Status: Prescription
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SYNJARDY XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208658
Product Number: 002
Approval Date: Dec 9, 2016
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SYNJARDY XR (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
12.5MG;1GM
Marketing Status: Prescription
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SYNJARDY XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12.5MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208658
Product Number: 003
Approval Date: Dec 9, 2016
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SYNJARDY XR (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
25MG;1GM
Marketing Status: Prescription
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SYNJARDY XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208658
Product Number: 004
Approval Date: Dec 9, 2016
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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