Orange Book product · Generic (ANDA)
AMMONIA N 13
AMMONIA N-13
At a glance
Feb 13, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
AMMONIA N-13
Strength
37.5mCi-800mCi/10ML (3.75-80mCi/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 204506
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of AMMONIA N-13
- 2007AMMONIA N 13Brand (NDA)
NDA 022119 · FEINSTEIN
- 2022AMMONIA N 13Generic (ANDA)
ANDA 211698 · UNIV ALAHAMA BIRM
- 2021AMMONIA N 13Generic (ANDA)
ANDA 215083 · METHODIST
- 2020AMMONIA N 13Generic (ANDA)
ANDA 211740 · UNIV WISCONSIN
- 2019AMMONIA N 13Generic (ANDA)
ANDA 209507 · UNIV TX SW MEDCTR
- 2018AMMONIA N 13Generic (ANDA)
ANDA 210524 · IONETIX
- 2016AMMONIA N 13Generic (ANDA)
ANDA 207025 · GEN HOSP
- 2015AMMONIA N 13Generic (ANDA)
ANDA 205687 · ESSENTIAL ISOTOPES
- 2015AMMONIA N 13Generic (ANDA)
ANDA 204457 · MIDWEST MEDCL
- 2015AMMONIA N 13Generic (ANDA)
ANDA 204510 · PETNET
- 2015AMMONIA N 13Generic (ANDA)
ANDA 203779 · 3D IMAGING DRUG
- 2015AMMONIA N 13Generic (ANDA)
ANDA 204547 · PRECISION NUCLEAR
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.
