RecallHawk

MYHIBBIN (MYCOPHENOLATE MOFETIL)

AZURITY

Summary

FDA approved MYHIBBIN (MYCOPHENOLATE MOFETIL) by AZURITY. NDA (New Drug) approval (Labeling) on 2025-06-27. SUSPENSION, ORAL.

Details

Source

Drug Approval

External ID

NDA216482-2

Action Date

2025-06-27

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

MYHIBBIN (generic: MYCOPHENOLATE MOFETIL), SUSPENSION, ORAL. Application: NDA216482

Company

Context & Analysis

AZURITY has 21 FDA actions in our database.

Frequently Asked Questions

How often does AZURITY have FDA actions?

AZURITY has 21 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA216482-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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