RecallHawk

Summary

FDA approved BACLOFEN by RUBICON RESEARCH. ANDA (Generic) approval (Manufacturing (CMC)) on 2025-06-03. SOLUTION, ORAL.

Details

Source

Drug Approval

External ID

ANDA214445-2

Action Date

2025-06-03

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

BACLOFEN, SOLUTION, ORAL. Application: ANDA214445

Context & Analysis

RUBICON RESEARCH has 34 FDA actions in our database.

Frequently Asked Questions

How often does RUBICON RESEARCH have FDA actions?

RUBICON RESEARCH has 34 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 "ANDA214445-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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