RecallHawk

Summary

FDA approved ONDANSETRON by SUN PHARM INDS LTD. ANDA (Generic) approval (Labeling) on 2025-11-24. TABLET, ORALLY DISINTEGRATING, ORAL.

Details

Source

Drug Approval

External ID

ANDA078602-9

Action Date

2025-11-24

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

ONDANSETRON, TABLET, ORALLY DISINTEGRATING, ORAL. Application: ANDA078602

Context & Analysis

SUN PHARM INDS LTD has 10 FDA actions in our database.

Frequently Asked Questions

How often does SUN PHARM INDS LTD have FDA actions?

SUN PHARM INDS LTD has 10 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 "ANDA078602-9" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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