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FDA Orange Book · active-ingredient family

Ammonia n-13

Ammonia n-13 is approved as 1 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AMMONIA N 13 · NDA 022119

1

Brand (NDA)

30

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
AMMONIA N 13RLDFEINSTEINNDA 022119APAug 23, 2007

Generic (ANDA) products (30)

ProductApplicantApplicationTEApproved
AMMONIA N 13UNIV ALAHAMA BIRMANDA 211698APNov 03, 2022
AMMONIA N 13METHODISTANDA 215083APJul 09, 2021
AMMONIA N 13UNIV WISCONSINANDA 211740APSep 09, 2020
AMMONIA N 13UNIV TX SW MEDCTRANDA 209507APNov 01, 2019
AMMONIA N 13IONETIXANDA 210524APDec 21, 2018
AMMONIA N 13GEN HOSPANDA 207025APFeb 03, 2016
AMMONIA N 13ESSENTIAL ISOTOPESANDA 205687—Dec 17, 2015
AMMONIA N 13MIDWEST MEDCLANDA 204457APNov 18, 2015
AMMONIA N 13PETNETANDA 204510APNov 02, 2015
AMMONIA N 133D IMAGING DRUGANDA 203779APOct 19, 2015
AMMONIA N 13PRECISION NUCLEARANDA 204547APAug 14, 2015
AMMONIA N 13CENTRAL RADIOPHARMANDA 204539—Jun 23, 2015
AMMONIA N 13BIOMEDCL RES FDNANDA 204352APMay 01, 2015
AMMONIA N 13NUKEMEDANDA 204455—Apr 23, 2015
AMMONIA N 13SOFIEANDA 204667—Apr 22, 2015
AMMONIA N 13NCM USA BRONX LLCANDA 204515APFeb 04, 2015
AMMONIA N 13WISCONSINANDA 204356—Dec 18, 2014
AMMONIA N 13MIPS CRFANDA 204535APNov 20, 2014
AMMONIA N 13BRIGHAM WOMENS HOSPANDA 203783APOct 30, 2014
AMMONIA N 13SOFIEANDA 204465APOct 23, 2014
AMMONIA N 13SHERTECH LABS LLCANDA 204366—Sep 19, 2014
AMMONIA N 13JOHNS HOPKINS UNIVANDA 204514APAug 19, 2014
AMMONIA N 13UNIV TX MD ANDERSONANDA 203933—Jun 27, 2014
AMMONIA N 13UCSF RODIOPHARMANDA 204496APMar 28, 2014
AMMONIA N 13×2WA UNIV SCH MEDANDA 204506APFeb 07, 2014
AMMONIA N 13KREITCHMAN PET CTRANDA 203938APDec 09, 2013
AMMONIA N 13UCLA BIOMEDICALANDA 203812APJun 27, 2013
AMMONIA N 13CARDINAL HLTH 414ANDA 203700APFeb 25, 2013
AMMONIA N 13MCPRFANDA 203321APFeb 25, 2013
AMMONIA N 13SOFIEANDA 203543APDec 14, 2012

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ammonia n-13 — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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