Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021995

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JANUVIA (SITAGLIPTIN PHOSPHATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021995
Product Number: 001
Approval Date: Oct 16, 2006
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JANUVIA (SITAGLIPTIN PHOSPHATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021995
Product Number: 002
Approval Date: Oct 16, 2006
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JANUVIA (SITAGLIPTIN PHOSPHATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: SITAGLIPTIN PHOSPHATE
Proprietary Name: JANUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021995
Product Number: 003
Approval Date: Oct 16, 2006
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information