TIZANIDINE HYDROCHLORIDE
Summary
FDA approved TIZANIDINE HYDROCHLORIDE by APOTEX INC. ANDA (Generic) approval (Labeling) on 2025-12-16. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
ANDA078868-7
Action Date
2025-12-16
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
TIZANIDINE HYDROCHLORIDE, CAPSULE, ORAL. Application: ANDA078868
Company
Context & Analysis
APOTEX INC has 17 FDA actions in our database.
Frequently Asked Questions
How often does APOTEX INC have FDA actions?
APOTEX INC has 17 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 "ANDA078868-7" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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