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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205687

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NDA 205687 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, Gen 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: 205687

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205687

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 205687

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13
ammonia n-13
 INJECTABLE;INTRAVENOUS 205687 ANDA Essential Isotopes 51760-003 51760-003-30 30 mL in 1 VIAL (51760-003-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength3.75-260mCi/ML
Approval Date:Dec 17, 2015TE:RLD:No


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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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