You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216743


✉ Email this page to a colleague

« Back to Dashboard


NDA 216743 describes ZITUVIMET, which is a drug marketed by Zydus Lifesciences and is included in two NDAs. It is available from two suppliers. Additional details are available on the ZITUVIMET profile page.

The generic ingredient in ZITUVIMET is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.
Summary for 216743
Tradename:ZITUVIMET
Applicant:Zydus Lifesciences
Ingredient:metformin hydrochloride; sitagliptin
Patents:0
Pharmacology for NDA: 216743
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
Suppliers and Packaging for NDA: 216743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZITUVIMET metformin hydrochloride; sitagliptin TABLET;ORAL 216743 NDA Zydus Pharmaceuticals (USA) Inc. 70710-1786 70710-1786-6 60 TABLET, FILM COATED in 1 BOTTLE (70710-1786-6)
ZITUVIMET metformin hydrochloride; sitagliptin TABLET;ORAL 216743 NDA Zydus Pharmaceuticals (USA) Inc. 70710-1786 70710-1786-8 180 TABLET, FILM COATED in 1 BOTTLE (70710-1786-8)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;50MG
Approval Date:Nov 3, 2023TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM;50MG
Approval Date:Nov 3, 2023TE:RLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links