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Details for New Drug Application (NDA): 203933

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NDA 203933 describes AMMONIA N 13, which is a drug marketed by Cardinal Health 414, Wa Univ Sch Med, Petnet, Ucla Biomedical, Johns Hopkins Univ, Ncm Usa Bronx Llc, Feinstein, Mcprf, Ma General Hosp, Univ Tx Md Anderson, Mips Crf, Kreitchman Pet Ctr, Central Radiopharm, Houston Cyclotron, Precision Nuclear, Biomedcl Res Fdn, Spectron Mrc Llc, Wi Medcl Cyclotron, Midwest Medcl, Global Isotopes Llc, Shertech Labs Llc, Iba Molecular N Am, 3d Imaging Drug, Brigham Womens Hosp, Essential Isotopes, and Ucsf Rodiopharm, 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 NDA: 203933

Tradename:
AMMONIA N 13
Applicant:
Univ Tx Md Anderson
Ingredient:
ammonia n-13
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Approval Date:Jun 27, 2014TE:APRLD:No


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