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Ammonia

Kreitchman PET Center
Kreitchman PET Center

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007Side EffectsNo adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system(6). To report SUSPECTED ADVERSE REACTIONS, contact Kreitchman PET Center at 212-305-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

6 ADVERSE REACTIONS

No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

Manufactured by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032

Distributed by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032

Ammonia

Ammonia

AMMONIA N-13 INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62072-456
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMMONIA N-13 37.5 mCi

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62072-456-56 8 in 1 VIAL, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203938 2013-12-09


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