EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Summary
FDA approved EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) by AMNEAL PHARMS NY. ANDA (Generic) approval (Labeling) on 2023-08-03. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
ANDA040765-16
Action Date
2023-08-03
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
EXTENDED PHENYTOIN SODIUM (generic: PHENYTOIN SODIUM), CAPSULE, ORAL. Application: ANDA040765
Company
Context & Analysis
AMNEAL PHARMS NY has 11 FDA actions in our database.
Frequently Asked Questions
How often does AMNEAL PHARMS NY have FDA actions?
AMNEAL PHARMS NY has 11 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 "ANDA040765-16" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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