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Federal Trade Commission
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204356

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NDA 204356 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, Iba Molecular N Am, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Petnet, Precision Nuclear, Shertech Labs Llc, 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 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 ActionRadiopharmaceutical 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 N 44338-002-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength3.75-260mCi/ML
Approval Date:Dec 18, 2014TE:RLD:No

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