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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204366

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NDA 204366 describes AMMONIA N 13, which is a drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens Hosp, Cardinal Hlth 414, Central Radiopharm, Essential Isotopes, Feinstein, Gen Hosp, Ionetix, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Methodist, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, Ucla Biomedical, Ucsf Rodiopharm, Univ Alahama Birm, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Wisconsin, Wa Univ Sch Med, and Wisconsin, and is included in thirty-one NDAs. It is available from eighteen suppliers. Additional details are available on the AMMONIA N 13 profile page.

The generic ingredient in AMMONIA N 13 is ammonia n-13. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.

Summary for 204366

Tradename:	AMMONIA N 13
Applicant:	Shertech Labs Llc
Ingredient:	ammonia n-13
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	3.75mCi-260mCi/ML
Approval Date:	Sep 19, 2014	TE:		RLD:	No

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