FDA — authorised 23 August 2007
- Application: NDA022119
- Marketing authorisation holder: FEINSTEIN
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 AMMONIA N 13 in United States
FDA authorised AMMONIA N 13 on 23 August 2007
Marketing authorisations
FDA — authorised 25 February 2013
- Application: ANDA203700
- Marketing authorisation holder: CARDINAL HLTH 414
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 25 February 2013
- Application: ANDA203321
- Marketing authorisation holder: MCPRF
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 June 2013
- Application: ANDA203812
- Marketing authorisation holder: UCLA BIOMEDICAL
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 December 2013
- Application: ANDA203938
- Marketing authorisation holder: KREITCHMAN PET CTR
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 February 2014
- Application: ANDA204506
- Marketing authorisation holder: WA UNIV SCH MED
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 March 2014
- Application: ANDA204496
- Marketing authorisation holder: UCSF RODIOPHARM
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 June 2014
- Application: ANDA203933
- Marketing authorisation holder: UNIV TX MD ANDERSON
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 August 2014
- Application: ANDA204514
- Marketing authorisation holder: JOHNS HOPKINS UNIV
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 September 2014
- Application: ANDA204366
- Marketing authorisation holder: SHERTECH LABS LLC
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 October 2014
- Application: ANDA204465
- Marketing authorisation holder: SOFIE
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 October 2014
- Application: ANDA203783
- Marketing authorisation holder: BRIGHAM WOMENS HOSP
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 20 November 2014
- Application: ANDA204535
- Marketing authorisation holder: MIPS CRF
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 December 2014
- Application: ANDA204356
- Marketing authorisation holder: WISCONSIN
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 February 2015
- Application: ANDA204515
- Marketing authorisation holder: NCM USA BRONX LLC
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 April 2015
- Application: ANDA204455
- Marketing authorisation holder: NUKEMED
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 1 May 2015
- Application: ANDA204352
- Marketing authorisation holder: BIOMEDCL RES FDN
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 June 2015
- Application: ANDA204539
- Marketing authorisation holder: CENTRAL RADIOPHARM
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 14 August 2015
- Application: ANDA204547
- Marketing authorisation holder: PRECISION NUCLEAR
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 October 2015
- Application: ANDA203779
- Marketing authorisation holder: 3D IMAGING DRUG
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 2 November 2015
- Application: ANDA204510
- Marketing authorisation holder: PETNET
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 November 2015
- Application: ANDA204457
- Marketing authorisation holder: MIDWEST MEDCL
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 December 2015
- Application: ANDA205687
- Marketing authorisation holder: ESSENTIAL ISOTOPES
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA210524
- Marketing authorisation holder: IONETIX
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 1 November 2019
- Application: ANDA209507
- Marketing authorisation holder: UNIV TX SW MEDCTR
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 September 2020
- Application: ANDA211740
- Marketing authorisation holder: UNIV WISCONSIN
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 3 November 2022
- Application: ANDA211698
- Marketing authorisation holder: UNIV ALAHAMA BIRM
- Local brand name: AMMONIA N 13
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
AMMONIA N 13 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is AMMONIA N 13 approved in United States?
Yes. FDA authorised it on 23 August 2007; FDA authorised it on 25 February 2013; FDA authorised it on 25 February 2013.
Who is the marketing authorisation holder for AMMONIA N 13 in United States?
FEINSTEIN holds the US marketing authorisation.