Orange Book product · Brand (NDA)
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
At a glance
Nov 30, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 1984
42 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Strength
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Dosage form
SOLUTION
Route
INTRAPERITONEAL
TE code
Not listed
Application
NDA 018883
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020183 · VANTIVE US HLTHCARE
- 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
- —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.
