Orange Book product · Brand (NDA)
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
POTASSIUM CHLORIDE; SODIUM CHLORIDE
At a glance
Nov 26, 2002
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 26, 2002
23 yr 11 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
NDA 017648
Product number
005
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.
- 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
- 2020POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%Generic (ANDA)
ANDA 212347 · FRESENIUS KABI USA
- 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.
