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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 203779

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NDA 203779 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 nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.

Summary for 203779

Tradename:	AMMONIA N 13
Applicant:	3d Imaging Drug
Ingredient:	ammonia n-13
Patents:	0

Pharmacology for NDA: 203779

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 203779

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	203779	ANDA	3D Imaging Drug Design and Development LLC	76451-013	76451-013-10	10 mL in 1 VIAL, GLASS (76451-013-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Approval Date:	Oct 19, 2015	TE:	AP	RLD:	No

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