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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203938


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NDA 203938 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 203938
Tradename:AMMONIA N 13
Applicant:Kreitchman Pet Ctr
Ingredient:ammonia n-13
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203938
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 203938
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203938 ANDA Kreitchman PET Center 62072-456 62072-456-56 8 mL in 1 VIAL, GLASS (62072-456-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Approval Date:Dec 9, 2013TE:APRLD:No

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