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FDA Drug information

Ammonia N 13

Read time: 1 mins
Marketing start date: 20 Apr 2025
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Summary of product characteristics


Adverse Reactions

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. 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 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.

Effective Time

20240109

Version

6

Spl Product Data Elements

Ammonia N 13 AMMONIA N-13 AMMONIA N-13 AMMONIA N-13

Application Number

ANDA203938

Brand Name

Ammonia N 13

Generic Name

AMMONIA N-13

Product Ndc

62072-456

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

product label

Spl Unclassified Section

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

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