ASPRUZYO SPRINKLE (RANOLAZINE)
Summary
FDA approved ASPRUZYO SPRINKLE (RANOLAZINE) by SPIL. NDA (New Drug) approval (Type 3 - New Dosage Form) on 2022-02-28. GRANULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA216018-1
Action Date
2022-02-28
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ASPRUZYO SPRINKLE (generic: RANOLAZINE), GRANULE, EXTENDED RELEASE, ORAL. Application: NDA216018
Company
Context & Analysis
SPIL has 3 FDA actions in our database.
Frequently Asked Questions
How often does SPIL have FDA actions?
SPIL has 3 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 "NDA216018-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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