U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 211566

Expand all

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 WORLDWIDE DMCC
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 WORLDWIDE DMCC
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 WORLDWIDE DMCC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top