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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209806

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SEGLUROMET (ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE)
2.5MG;500MG
Marketing Status: Prescription
Active Ingredient: ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SEGLUROMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209806
Product Number: 001
Approval Date: Dec 19, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SEGLUROMET (ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE)
2.5MG;1GM
Marketing Status: Prescription
Active Ingredient: ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SEGLUROMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209806
Product Number: 002
Approval Date: Dec 19, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SEGLUROMET (ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE)
7.5MG;500MG
Marketing Status: Prescription
Active Ingredient: ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SEGLUROMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209806
Product Number: 003
Approval Date: Dec 19, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SEGLUROMET (ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE)
7.5MG;1GM
Marketing Status: Prescription
Active Ingredient: ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: SEGLUROMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209806
Product Number: 004
Approval Date: Dec 19, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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