Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216482
Company: AZURITY

• Medication Guide

Products on NDA 216482

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYHIBBIN	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216482

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2024	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216482s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216482Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216482Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216482s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216482Orig1s002ltr.pdf
08/13/2024	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216482Orig1s001ltr.pdf

Labels for NDA 216482

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216482s002lbl.pdf
06/27/2025	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216482s002lbl.pdf
05/01/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216482s000lbl.pdf