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Last Updated: November 2, 2024

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 Hlth 414, Central Radiopharm, Decatur, Essential Isotopes, Feinstein, Gen Hosp, Ionetix, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Methodist, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, Ucla Biomedical, Ucsf Rodiopharm, Univ Alahama Birm, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Wisconsin, Wa Univ Sch Med, and Wisconsin, and is included in thirty-one NDAs. It is available from twenty 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 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
Patents:0
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 40089-113-20 20 mL in 1 VIAL, GLASS (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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