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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022044

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JANUMET (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE)
500MG;EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022044
Product Number: 001
Approval Date: Mar 30, 2007
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
JANUMET (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE)
1GM;EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM;EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022044
Product Number: 002
Approval Date: Mar 30, 2007
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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