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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
McKesson
Chinese Patent Office
Moodys
Medtronic
Dow
Queensland Health
Cerilliant
Deloitte

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204547

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NDA 204547 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: 204547

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

Pharmacology for NDA: 204547

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 204547

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONIA N 13
ammonia n-13
INJECTABLE;INTRAVENOUS 204547 ANDA Precision Nuclear LLC 52768-100 52768-100-30 30 mL in 1 VIAL (52768-100-30)
AMMONIA N 13
ammonia n-13
INJECTABLE;INTRAVENOUS 204547 ANDA Precision Nuclear LLC 52768-100 52768-100-50 50 mL in 1 VIAL (52768-100-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength3.75-260mCi/ML
Approval Date:Aug 14, 2015TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Fuji
Julphar
Cipla
Fish and Richardson
Healthtrust
UBS
Teva
Express Scripts

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