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Generated: September 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203321

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NDA 203321 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 203321
Tradename:AMMONIA N 13
Applicant:Mcprf
Ingredient:ammonia n-13
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203321
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 203321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203321 ANDA Mayo Clinic 52670-552 52670-552-30 30 mL in 1 VIAL, SINGLE-DOSE (52670-552-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Approval Date:Feb 25, 2013TE:APRLD:No

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