MONTELUKAST SODIUM
Summary
FDA approved MONTELUKAST SODIUM by PHARMACO. ANDA (Generic) approval (Labeling) on 2025-06-13. TABLET, CHEWABLE, ORAL.
Details
Source
Drug Approval
External ID
ANDA091588-21
Action Date
2025-06-13
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
MONTELUKAST SODIUM, TABLET, CHEWABLE, ORAL. Application: ANDA091588
Company
Context & Analysis
PHARMACO has 2 FDA actions in our database.
Frequently Asked Questions
How often does PHARMACO have FDA actions?
PHARMACO 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 "ANDA091588-21" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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