Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211566

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ZITUVIO (SITAGLIPTIN)
25MG
Marketing Status: Prescription

Active Ingredient: SITAGLIPTIN
Proprietary Name: ZITUVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211566
Product Number: 001
Approval Date: Oct 18, 2023
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information

ZITUVIO (SITAGLIPTIN)
50MG
Marketing Status: Prescription

Active Ingredient: SITAGLIPTIN
Proprietary Name: ZITUVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211566
Product Number: 002
Approval Date: Oct 18, 2023
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information

ZITUVIO (SITAGLIPTIN)
100MG
Marketing Status: Prescription

Active Ingredient: SITAGLIPTIN
Proprietary Name: ZITUVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211566
Product Number: 003
Approval Date: Oct 18, 2023
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information