RecallHawk

Summary

FDA approved ONDANSETRON by HIKMA FARMACEUTICA. ANDA (Generic) approval (Labeling) on 2026-04-08. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

ANDA076781-20

Action Date

2026-04-08

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

ONDANSETRON, INJECTABLE, INJECTION. Application: ANDA076781

Context & Analysis

HIKMA FARMACEUTICA has 4 FDA actions in our database.

Frequently Asked Questions

How often does HIKMA FARMACEUTICA have FDA actions?

HIKMA FARMACEUTICA has 4 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 "ANDA076781-20" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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