Product Details for NDA 021995
JANUVIA (SITAGLIPTIN PHOSPHATE)
EQ 25MG BASE
Marketing Status: Prescription
EQ 50MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
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)
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
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)
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
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
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