Orange Book product · Generic (ANDA)
DEXTROSE 5% AND SODIUM CHLORIDE 0.9%
DEXTROSE; SODIUM CHLORIDE
At a glance
Sep 14, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 14, 2020
5 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROSE; SODIUM CHLORIDE
Strength
5GM/100ML;900MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 211211
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXTROSE; SODIUM CHLORIDE
- 1988DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERBrand (NDA)
NDA 019631 · B BRAUN
- 1985DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERBrand (NDA)
NDA 019482 · ABBOTT
- 1985DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERBrand (NDA)
NDA 019486 · ABBOTT
- 1985DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 019484 · ABBOTT
- 1985DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019483 · ABBOTT
- —DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERBrand (NDA)
NDA 018386 · B BRAUN
- —DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 018229 · B BRAUN
- —DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 018047 · B BRAUN
- —DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 016696 · BAXTER HLTHCARE
- —DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 018030 · B BRAUN
- —DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 016697 · BAXTER HLTHCARE
- —DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 018096 · HOSPIRA
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.
