Orange Book product · Brand (NDA)
DEXTROSE 50%
DEXTROSE
At a glance
Jun 03, 1986
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 03, 1986
40 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROSE
Strength
500MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 019445
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1995DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019971 · DHL
- 1992DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020179 · BAXTER HLTHCARE
- 1991DEXTROSE 50% IN PLASTIC CONTAINERBrand (NDA)
NDA 020047 · BAXTER HLTHCARE
- 1989DEXTROSE 50% IN PLASTIC CONTAINERBrand (NDA)
NDA 019894 · ICU MEDICAL INC
- 1989DEXTROSE 70% IN PLASTIC CONTAINERBrand (NDA)
NDA 019893 · OTSUKA ICU MEDCL
- 1988DEXTROSE 10% IN PLASTIC CONTAINERBrand (NDA)
NDA 019626 · B BRAUN
- 1985DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019479 · HOSPIRA
- 1985DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019466 · HOSPIRA
- 1985DEXTROSE 30% IN PLASTIC CONTAINERBrand (NDA)
NDA 019345 · OTSUKA ICU MEDCL
- 1985DEXTROSE 60% IN PLASTIC CONTAINERBrand (NDA)
NDA 019346 · HOSPIRA
- 1984DEXTROSE 38.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 018923 · ABBOTT
- 1984DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019222 · ICU MEDICAL INC
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.

