BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204514

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NDA 204514 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 204514
Tradename:AMMONIA N 13
Applicant:Johns Hopkins Univ
Ingredient:ammonia n-13
Formulation / Manufacturing:see details
Pharmacology for NDA: 204514
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 204514
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204514 ANDA The Johns Hopkins University 40089-113 N 40089-113-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Approval Date:Aug 19, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson

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