OPFOLDA

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

Company

DUNS: 080932337

Effective Date

October 6, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Miglustat(65 mg in 1 1)

Products1

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

NDC Product Code

71904-300

Application Number

NDA215211

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 1, 2023

Ingredients

Code: ADN3S497AZClass: ACTIBQuantity: 65 mg in 1 1