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Serving leading biopharmaceutical companies globally:

Medtronic
Deloitte
Dow
UBS
Mallinckrodt
US Department of Justice
Express Scripts
Teva
Chubb
Cantor Fitzgerald

Generated: January 18, 2018

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 Health 414, Central Radiopharm, Essential Isotopes, Feinstein, Gen Hosp, Global Isotopes Llc, Houston Cyclotron, Iba Molecular N Am, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Petnet, Precision Nuclear, Shertech Labs Llc, 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 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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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Covington
Accenture
Johnson and Johnson
Express Scripts
Daiichi Sankyo
Mallinckrodt
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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