RecallHawk

Summary

FDA approved TIZANIDINE by UNICHEM LABS LTD. ANDA (Generic) approval (Labeling) on 2025-03-13. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA091283-18

Action Date

2025-03-13

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

TIZANIDINE, TABLET, ORAL. Application: ANDA091283

Context & Analysis

UNICHEM LABS LTD has 3 FDA actions in our database.

Frequently Asked Questions

How often does UNICHEM LABS LTD have FDA actions?

UNICHEM LABS LTD has 3 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 "ANDA091283-18" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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