Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG;EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202270
Product Number: 001
Approval Date: Feb 2, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202270
Product Number: 002
Approval Date: Feb 2, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202270
Product Number: 003
Approval Date: Feb 2, 2012
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information