Orange Book product · Generic (ANDA)
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
POTASSIUM CHLORIDE; SODIUM CHLORIDE
At a glance
Sep 17, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 17, 2020
5 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
POTASSIUM CHLORIDE; SODIUM CHLORIDE
Strength
150MG/100ML;450MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 212347
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POTASSIUM CHLORIDE; SODIUM CHLORIDE
- 2002POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%Brand (NDA)
NDA 017648 · BAXTER HLTHCARE
- 1989POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019708 · B BRAUN
- 1988POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019686 · OTSUKA ICU MEDCL
- 1982SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERBrand (NDA)
NDA 018722 · B BRAUN
- 2008POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078446 · OTSUKA ICU MEDCL
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.
