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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216778


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NDA 216778 describes ZITUVIMET XR, which is a drug marketed by Zydus Lifesciences and is included in one NDA. It is available from two suppliers. Additional details are available on the ZITUVIMET XR profile page.

The generic ingredient in ZITUVIMET XR 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 216778
Tradename:ZITUVIMET XR
Applicant:Zydus Lifesciences
Ingredient:metformin hydrochloride; sitagliptin
Patents:0
Pharmacology for NDA: 216778
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
Suppliers and Packaging for NDA: 216778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA Zydus Pharmaceuticals USA Inc. 70710-1804 70710-1804-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6)
ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778 NDA Zydus Pharmaceuticals USA Inc. 70710-1805 70710-1805-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1805-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;50MG
Approval Date:Jul 18, 2024TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;50MG
Approval Date:Jul 18, 2024TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;100MG
Approval Date:Jul 18, 2024TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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