RANOLAZINE
Summary
FDA approved RANOLAZINE by I3 PHARMS. ANDA (Generic) approval on 2022-04-27. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA213517-1
Action Date
2022-04-27
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
RANOLAZINE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA213517
Company
Context & Analysis
I3 PHARMS has 2 FDA actions in our database.
Frequently Asked Questions
How often does I3 PHARMS have FDA actions?
I3 PHARMS has 2 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 "ANDA213517-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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