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FDA Product

Pranactin-Citric

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Pranactin-Citric

59148-023

Regulatory Information

59148-023

NDA020586

C73594

September 18, 2009

USA

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

008314390

Active Ingredients

UREA C-13

Quantity: 75 mg in 3000 mg

Code: W6KX9E6D8X

Class Code: ACTIM

ANHYDROUS CITRIC ACID

Quantity: 2000 mg in 3000 mg

Code: XF417D3PSL

Class Code: IACT

MANNITOL

Quantity: 775 mg in 3000 mg

Code: 3OWL53L36A

Class Code: IACT

ASPARTAME

Quantity: 150 mg in 3000 mg

Code: Z0H242BBR1

Class Code: IACT

Active Moieties

UREA C-13

Code: W6KX9E6D8X

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