Pranactin-Citric

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

Company

DUNS: 008314390

Effective Date

August 24, 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Urea C-13(75 mg in 3000 mg)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

008314390

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

NDC Product Code

59148-023

Application Number

NDA020586

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 18, 2009

Ingredients

Code: W6KX9E6D8XClass: ACTIMQuantity: 75 mg in 3000 mg

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 2000 mg in 3000 mg

MANNITOLInactive

Code: 3OWL53L36AClass: IACTQuantity: 775 mg in 3000 mg

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACTQuantity: 150 mg in 3000 mg