PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE (PRAMIPEXOLE DIHYDROCHLORIDE)
Summary
FDA approved PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE (PRAMIPEXOLE DIHYDROCHLORIDE) by XIAMEN LP PHARM CO. ANDA (Generic) approval (Labeling) on 2025-02-19. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA212797-2
Action Date
2025-02-19
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE (generic: PRAMIPEXOLE DIHYDROCHLORIDE), TABLET, EXTENDED RELEASE, ORAL. Application: ANDA212797
Company
Context & Analysis
XIAMEN LP PHARM CO has 5 FDA actions in our database.
Frequently Asked Questions
How often does XIAMEN LP PHARM CO have FDA actions?
XIAMEN LP PHARM CO has 5 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 "ANDA212797-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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