Extended Phenytoin Sodium
Extended Phenytoin Sodium, USP Rx Only These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES Initial U.S. Approval: 1953
Approved
Approval ID
f163208c-25e7-415b-ae17-9f5f5870e6e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2020
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenytoin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-479
Application NumberANDA040765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2020
FDA Product Classification
INGREDIENTS (1)
PHENYTOIN SODIUMActive
Quantity: 100 mg in 1 1
Code: 4182431BJH
Classification: ACTIB