RecallHawk

LEVOCETIRIZINE DIHYDROCHLORIDE

SYNTHON BV

Summary

FDA approved LEVOCETIRIZINE DIHYDROCHLORIDE by SYNTHON BV. ANDA (Generic) approval (Labeling) on 2025-07-11. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA090229-19

Action Date

2025-07-11

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

LEVOCETIRIZINE DIHYDROCHLORIDE, TABLET, ORAL. Application: ANDA090229

Company

Context & Analysis

SYNTHON BV has 2 FDA actions in our database.

Frequently Asked Questions

How often does SYNTHON BV have FDA actions?

SYNTHON BV has 2 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 "ANDA090229-19" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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