ROPINIROLE
Summary
FDA approved ROPINIROLE by ELITE LABS INC. ANDA (Generic) approval on 2025-11-10. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA217862-1
Action Date
2025-11-10
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
ROPINIROLE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA217862
Company
Context & Analysis
ELITE LABS INC has 6 FDA actions in our database.
Frequently Asked Questions
How often does ELITE LABS INC have FDA actions?
ELITE LABS INC has 6 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 "ANDA217862-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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