Orange Book product · Brand (NDA)
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
At a glance
Dec 04, 1992
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 04, 1992
34 yr ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Strength
18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Dosage form
SOLUTION
Route
INTRAPERITONEAL
TE code
AT
Application
NDA 020183
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.
- 1992DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020163 · VANTIVE US HLTHCARE
- 1992DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINERBrand (NDA)
NDA 020171 · FRESENIUS MEDCL
- 1986DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 018460 · B BRAUN
- 1984DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 018883 · FRESENIUS MEDCL
- —DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 018379 · FRESENIUS MEDCL
- —DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 017512 · VANTIVE US HLTHCARE
- 1994INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 020374 · FRESENIUS
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.
