Orange Book product · Brand (NDA)
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
At a glance
Feb 24, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 24, 1988
38 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Strength
10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019634
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1988POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019685 · OTSUKA ICU MEDCL
- 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
- 2021POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 211428 · 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.
