MONTELUKAST SODIUM (MONTELUKAST)
Summary
FDA approved MONTELUKAST SODIUM (MONTELUKAST) by AMNEAL PHARMS. ANDA (Generic) approval (Labeling) on 2025-04-16. TABLET, CHEWABLE, ORAL.
Details
Source
Drug Approval
External ID
ANDA205107-1
Action Date
2025-04-16
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
MONTELUKAST SODIUM (generic: MONTELUKAST), TABLET, CHEWABLE, ORAL. Application: ANDA205107
Company
Context & Analysis
AMNEAL PHARMS has 43 FDA actions in our database.
Frequently Asked Questions
How often does AMNEAL PHARMS have FDA actions?
AMNEAL PHARMS has 43 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 "ANDA205107-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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