Orange Book product · Generic (ANDA)
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
DEXTROSE; POTASSIUM CHLORIDE
Generic (ANDA)ANDA 212346TE APRX FRESENIUS KABI USA
At a glance
Sep 10, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 2020
5 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROSE; POTASSIUM CHLORIDE
Strength
5GM/100ML;75MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 212346
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
- 1989POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019699 · B BRAUN
- 1982POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 018744 · B BRAUN
- —DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERBrand (NDA)
NDA 017634 · BAXTER HLTHCARE
- —POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 018371 · 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.
