FDA Orange Book · active-ingredient family
Ammonia n-13
Ammonia n-13: 1 brand, 30 generics; first approved Aug 23, 2007; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 30 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
30
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- AMMONIA N 13RLDRSFEINSTEINNDA 0221192007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP
Generic (ANDA) products (30)
Abbreviated applications
- AMMONIA N 13UNIV ALAHAMA BIRMANDA 2116982022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13METHODISTANDA 2150832021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13UNIV WISCONSINANDA 2117402020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13UNIV TX SW MEDCTRANDA 2095072019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13IONETIXANDA 2105242018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13GEN HOSPANDA 2070252016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13ESSENTIAL ISOTOPESANDA 2056872015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13MIDWEST MEDCLANDA 2044572015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13PETNETANDA 2045102015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 133D IMAGING DRUGANDA 2037792015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13PRECISION NUCLEARANDA 2045472015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13CENTRAL RADIOPHARMANDA 2045392015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75-260mCi/ML INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13BIOMEDCL RES FDNANDA 2043522015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13NUKEMEDANDA 2044552015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13SOFIEANDA 2046672015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18.8mCi-188mCi/5ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13NCM USA BRONX LLCANDA 2045152015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13WISCONSINANDA 2043562014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13MIPS CRFANDA 2045352014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13BRIGHAM WOMENS HOSPANDA 2037832014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13SOFIEANDA 2044652014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13SHERTECH LABS LLCANDA 2043662014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13JOHNS HOPKINS UNIVANDA 2045142014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13UNIV TX MD ANDERSONANDA 2039332014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Discontinued — - AMMONIA N 13UCSF RODIOPHARMANDA 2044962014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13WA UNIV SCH MEDANDA 20450620142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP 37.5mCi-800mCi/10ML (3.75-80mCi/ML) INJECTABLE INTRAVENOUS Rx — - AMMONIA N 13KREITCHMAN PET CTRANDA 2039382013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13UCLA BIOMEDICALANDA 2038122013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13CARDINAL HLTH 414ANDA 2037002013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13MCPRFANDA 2033212013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE INTRAVENOUS Rx AP - AMMONIA N 13RSSOFIEANDA 2035432012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75mCi-260mCi/ML INJECTABLE INTRAVENOUS Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
19 yr 3 mo ago
Most recent approval
6 mo ago
Approvals span 2007–2026 across 31 FDA applications.
Brand (NDA) 13%
Generic (ANDA) 3097%
Ammonia n-13: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
