Orange Book product · Generic (ANDA)
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
At a glance
Nov 09, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Strength
20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 211428
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
- 1988POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019685 · OTSUKA ICU MEDCL
- 1988DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019634 · B BRAUN
- 1985POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019367 · BAXTER HLTHCARE
- —DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 017608 · OTSUKA ICU MEDCL
- —DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 017510 · B BRAUN
- —DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 018499 · MILES
- —LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 016679 · BAXTER HLTHCARE
- 2022DEXTROSE 5% AND LACTATED RINGER'SGeneric (ANDA)
ANDA 210332 · 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.
