Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202270

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JANUMET XR (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE)
500MG;EQ 50MG BASE
Marketing Status: Prescription

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 LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JANUMET XR (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE)
1GM;EQ 50MG BASE
Marketing Status: Prescription

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 LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JANUMET XR (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE)
1GM;EQ 100MG BASE
Marketing Status: Prescription

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 LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information