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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210524

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NDA 210524 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 210524

Tradename:	AMMONIA N 13
Applicant:	Ionetix
Ingredient:	ammonia n-13
Patents:	0

Pharmacology for NDA: 210524

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 210524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	210524	ANDA	Ionetix Corporation	71162-001	71162-001-05	5 mL in 1 SYRINGE, PLASTIC (71162-001-05)
AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	210524	ANDA	Ionetix Corporation	71162-001	71162-001-10	1 VIAL, GLASS in 1 CONTAINER (71162-001-10) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)
Approval Date:	Dec 21, 2018	TE:	AP	RLD:	No

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