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ZITUVIMET

NDA

METFORMIN HYDROCHLORIDE; SITAGLIPTIN | N216743 | ZYDUS LIFESCIENCES GLOBAL FZE

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2026	SUPPL -5	View Letter (PDF)
Nov 6, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG;50MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 3, 2023

No patent or exclusivity listings for this strength.

#002 — 1GM;50MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 3, 2023