RecallHawk

CORTISPORIN

MONARCH PHARMS

Summary

FDA approved CORTISPORIN by MONARCH PHARMS. NDA (New Drug) approval (Labeling) on 2025-08-08. SOLUTION/DROPS, OTIC.

Details

Source

Drug Approval

External ID

NDA050479-21

Action Date

2025-08-08

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

CORTISPORIN, SOLUTION/DROPS, OTIC. Application: NDA050479

Context & Analysis

Frequently Asked Questions

How often does MONARCH PHARMS have FDA actions?

This is the only FDA action we have on record for MONARCH PHARMS in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA050479-21" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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