RecallHawk

Summary

FDA approved IBUPROFEN by ONESOURCE SPECIALTY. ANDA (Generic) approval (Labeling) on 2025-04-01. CAPSULE, ORAL.

Details

Source

Drug Approval

External ID

ANDA204469-8

Action Date

2025-04-01

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

IBUPROFEN, CAPSULE, ORAL. Application: ANDA204469

Context & Analysis

ONESOURCE SPECIALTY has 11 FDA actions in our database.

Frequently Asked Questions

How often does ONESOURCE SPECIALTY have FDA actions?

ONESOURCE SPECIALTY has 11 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 "ANDA204469-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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