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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216778
Company: ZYDUS LIFESCIENCES

Medication Guide

Products on NDA 216778

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZITUVIMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN	500MG;50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ZITUVIMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN	1GM;50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ZITUVIMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN	1GM;100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216778

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2024	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216778s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216778Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2026	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216778s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216743Orig1s006;216778Orig1s004ltr.pdf
05/11/2026	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216778Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216778Orig1s003ltr.pdf

Labels for NDA 216778

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2026	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216778s004lbl.pdf
05/11/2026	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216778Orig1s003lbl.pdf
07/18/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216778s000lbl.pdf

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