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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216593
Company: NOVA LABS LTD

Medication Guide

Products on NDA 216593

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XROMI	HYDROXYUREA	100MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216593

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2024	ORIG-2	Approval	Efficacy	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216593Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216593Orig2s000TOC.cfm
04/04/2024	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216593Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216593Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216593Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2024	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216593Orig1s001ltr.pdf

Labels for NDA 216593

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2024	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593Orig2s000lbl.pdf
10/18/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593s001lbl.pdf
04/04/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593s000lbl.pdf

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