PHENYTOIN
Approved
Approval ID
9367137e-200c-48c6-9634-135e1faeb101
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-815
Application NumberANDA040298
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENYTOIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2010
FDA Product Classification
INGREDIENTS (1)
PHENYTOIN SODIUMActive
Quantity: 100 mg in 1 1
Code: 4182431BJH
Classification: ACTIB