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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204352

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NDA 204352 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-one 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-one suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.

Summary for 204352

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204352

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 204352

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204352 ANDA Biomedical Research Foundation of Northwest Louisiana 24562-004 24562-004-30 30 mL in 1 VIAL, GLASS (24562-004-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML)
Approval Date:May 1, 2015TE:APRLD:No


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