Orange Book product · Brand (NDA)
POTASSIUM PHOSPHATES
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
At a glance
Nov 26, 2019
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 26, 2019
6 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Strength
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 212832
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 218343 · AMNEAL
- 2019POTASSIUM PHOSPHATESBrand (NDA)
NDA 212121 · CMP DEV LLC
- 2026POTASSIUM PHOSPHATESGeneric (ANDA)
ANDA 220373 · CAPLIN
- 2025POTASSIUM PHOSPHATESGeneric (ANDA)
ANDA 217459 · HOSPIRA
- 2025POTASSIUM PHOSPHATESGeneric (ANDA)
ANDA 217892 · CIPLA
- 2024POTASSIUM PHOSPHATESGeneric (ANDA)
ANDA 217726 · SOMERSET THERAPS LLC
- 2023POTASSIUM PHOSPHATESGeneric (ANDA)
ANDA 216344 · AMNEAL
- 2023POTASSIUM PHOSPHATESGeneric (ANDA)
ANDA 216274 · AM REGENT
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.
