RecallHawk

Summary

FDA approved ONDANSETRON by CHARTWELL MOLECULES. ANDA (Generic) approval (Labeling) on 2024-12-16. TABLET, ORALLY DISINTEGRATING, ORAL.

Details

Source

Drug Approval

External ID

ANDA077406-8

Action Date

2024-12-16

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

ONDANSETRON, TABLET, ORALLY DISINTEGRATING, ORAL. Application: ANDA077406

Context & Analysis

CHARTWELL MOLECULES has 8 FDA actions in our database.

Frequently Asked Questions

How often does CHARTWELL MOLECULES have FDA actions?

CHARTWELL MOLECULES has 8 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 "ANDA077406-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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