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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Accenture
Merck
Daiichi Sankyo
Covington
McKinsey
Fish and Richardson
Julphar

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203543

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NDA 203543 describes AMMONIA N 13, which is a drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens Hosp, Cardinal Health 414, Central Radiopharm, Essential Isotopes, Feinstein, Gen Hosp, Global Isotopes Llc, Houston Cyclotron, 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, Wa Univ Sch Med, and Wi Medcl Cyclotron, and is included in twenty-six NDAs. It is available from twenty-two 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-two suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.
Summary for 203543
Tradename:AMMONIA N 13
Applicant:Houston Cyclotron
Ingredient:ammonia n-13
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203543
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 203543
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203543 ANDA Houston Cyclotron Partners LP dba Cyclotope 47584-003 N 47584-003-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength3.75-260mCi/ML
Approval Date:Dec 14, 2012TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Citi
Johnson and Johnson
Merck
Baxter
Cerilliant
AstraZeneca
Cipla
Chubb

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