Orange Book product · Generic (ANDA)
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
At a glance
Mar 09, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 09, 2021
5 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Strength
5GM/100ML;74.5MG/100ML;450MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 213523
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
- 1988POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019691 · OTSUKA ICU MEDCL
- 1988POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERBrand (NDA)
NDA 019630 · B BRAUN
- 1986POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERBrand (NDA)
NDA 018876 · ICU MEDICAL INC
- 1985POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019308 · BAXTER HLTHCARE
- 1983POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERBrand (NDA)
NDA 018365 · OTSUKA ICU MEDCL
- 1983POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 018362 · OTSUKA ICU MEDCL
- 1982DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQBrand (NDA)
NDA 018037 · BAXTER HLTHCARE
- 1982DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERBrand (NDA)
NDA 018629 · BAXTER HLTHCARE
- —DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%Brand (NDA)
NDA 018268 · B BRAUN
- —DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINERBrand (NDA)
NDA 018008 · BAXTER HLTHCARE
- 2021POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 212348 · FRESENIUS KABI USA
- 2021POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%Generic (ANDA)
ANDA 213445 · FRESENIUS KABI USA
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.
