Product Details for NDA 209806
SEGLUROMET (ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE)
2.5MG;500MG
Marketing Status: Prescription
2.5MG;1GM
Marketing Status: Prescription
7.5MG;500MG
Marketing Status: Prescription
7.5MG;1GM
Marketing Status: Prescription
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)
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
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)
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
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)
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
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
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