Orange Book product · Brand (NDA)
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
Strength
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 017378
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.
- 1989ISOLYTE S IN PLASTIC CONTAINERBrand (NDA)
NDA 019711 · B BRAUN
- 1985SYNOVALYTE IN PLASTIC CONTAINERBrand (NDA)
NDA 019326 · BAXTER HLTHCARE
- 1984PHYSIOLYTE IN PLASTIC CONTAINERBrand (NDA)
NDA 019024 · B BRAUN
- 1982PHYSIOSOL IN PLASTIC CONTAINERBrand (NDA)
NDA 017637 · OTSUKA ICU MEDCL
- —ISOLYTE S IN PLASTIC CONTAINERBrand (NDA)
NDA 018252 · B BRAUN
- —NORMOSOL-R IN PLASTIC CONTAINERBrand (NDA)
NDA 017586 · OTSUKA ICU MEDCL
- —PHYSIOSOL IN PLASTIC CONTAINERBrand (NDA)
NDA 018406 · HOSPIRA INC
- 2022MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5Generic (ANDA)
ANDA 215370 · FRESENIUS KABI USA
- 2022MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4Generic (ANDA)
ANDA 215371 · FRESENIUS KABI USA
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.
