Details for New Drug Application (NDA): 209507

NDA 209507 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, 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 twenty 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. Twenty suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.

Summary for 209507

Tradename:	AMMONIA N 13
Applicant:	Univ Tx Sw Medctr
Ingredient:	ammonia n-13
Patents:	0

Pharmacology for NDA: 209507

Mechanism of Action

Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 209507

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	209507	ANDA	The University of Texas Southwestern Medical Center	70681-001	70681-001-30	30 mL in 1 VIAL, GLASS (70681-001-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Approval Date:	Nov 1, 2019	TE:	AP	RLD:	No

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