You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204356

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 204356 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 204356

Tradename:	AMMONIA N 13
Applicant:	Wi Medcl Cyclotron
Ingredient:	ammonia n-13
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204356

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 204356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	204356	ANDA	Wisconsin Medical Cyclotron, LLC	44338-002	44338-002-30	30 mL in 1 VIAL, GLASS (44338-002-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	3.75-260mCi/ML
Approval Date:	Dec 18, 2014	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School

Medtronic

Merck

Johnson and Johnson

Colorcon

McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.