Extended Phenytoin Sodium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 128385585

Effective Date

November 12, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Phenytoin(100 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Aphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

71610-479

Application Number

ANDA040765

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 12, 2020

Ingredients

Code: 4182431BJHClass: ACTIBQuantity: 100 mg in 1 1