Orange Book product · Brand (NDA)
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
At a glance
Aug 09, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 09, 1993
33 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
Strength
5GM/100ML;30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019843
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
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.
