ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE)
Summary
FDA approved ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) by AUCTA. ANDA (Generic) approval on 2025-04-29. FOR SOLUTION, ORAL.
Details
Source
Drug Approval
External ID
ANDA218645-1
Action Date
2025-04-29
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
ZELVYSIA (generic: SAPROPTERIN DIHYDROCHLORIDE), FOR SOLUTION, ORAL. Application: ANDA218645
Company
Context & Analysis
AUCTA has 4 FDA actions in our database.
Frequently Asked Questions
How often does AUCTA have FDA actions?
AUCTA has 4 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 "ANDA218645-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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