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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204515

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NDA 204515 describes AMMONIA N 13, which is a drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens Hosp, Cardinal Hlth 414, Central Radiopharm, Decatur, Essential Isotopes, Feinstein, Gen Hosp, Ionetix, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, Spectron Mrc Llc, Ucla Biomedical, Ucsf Rodiopharm, Univ Tx Md Anderson, Univ Tx Sw Medctr, Wa Univ Sch Med, and Wi Medcl Cyclotron, and is included in twenty-eight 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 204515

Tradename:	AMMONIA N 13
Applicant:	Ncm Usa Bronx Llc
Ingredient:	ammonia n-13
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204515

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 204515

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	204515	ANDA	NCM USA Bronx LLC	24445-643	24445-643-30	30 mL in 1 VIAL, GLASS (24445-643-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	3.75-260mCi/mL
Approval Date:	Feb 4, 2015	TE:		RLD:	No

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