Orange Book product · Brand (NDA)
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
SODIUM CHLORIDE
At a glance
May 17, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 17, 1985
41 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM CHLORIDE
Strength
900MG/100ML
Dosage form
SOLUTION FOR SLUSH
Route
IRRIGATION
TE code
Not listed
Application
NDA 019319
Product number
002
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.
- 2012SODIUM CHLORIDE 0.9%Brand (NDA)
NDA 202832 · MEDEFIL INC
- 2006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 021569 · LIEBEL-FLARSHEIM
- 1998SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019217 · ICU MEDICAL INC
- 1992SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 020178 · BAXTER HLTHCARE
- 1992BRONCHO SALINEBrand (NDA)
NDA 019912 · BLAIREX
- 1988SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 019759 · HOSPIRA
- 1988SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 019635 · B BRAUN
- 1987SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINERBrand (NDA)
NDA 019329 · ABRAXIS PHARM
- 1985SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 016677 · BAXTER HLTHCARE
- 1985SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019480 · HOSPIRA
- 1985SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019465 · HOSPIRA
- 1984SODIUM CHLORIDE 14.6%Brand (NDA)
NDA 018897 · HOSPIRA
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.
