Orange Book product · Brand (NDA)
STERILE WATER FOR INJECTION
STERILE WATER FOR INJECTION
At a glance
Oct 27, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 1982
44 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
STERILE WATER FOR INJECTION
Strength
100% (50ML)
Dosage form
LIQUID
Route
N/A
TE code
Not listed
Application
NDA 018801
Product number
004
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.
- 1989STERILE WATER FOR INJECTION IN PLASTIC CONTAINERBrand (NDA)
NDA 019869 · OTSUKA ICU MEDCL
- 1988STERILE WATER FOR INJECTION IN PLASTIC CONTAINERBrand (NDA)
NDA 019633 · B BRAUN
- 1984STERILE WATER FOR INJECTION IN PLASTIC CONTAINERBrand (NDA)
NDA 019077 · B BRAUN
- 1982BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERBrand (NDA)
NDA 018802 · HOSPIRA
- 1982STERILE WATER FOR INJECTION IN PLASTIC CONTAINERBrand (NDA)
NDA 018632 · BAXTER HLTHCARE
- —STERILE WATER FOR INJECTION IN PLASTIC CONTAINERBrand (NDA)
NDA 018233 · OTSUKA ICU MEDCL
- 2023STERILE WATER FOR INJECTIONGeneric (ANDA)
ANDA 217341 · AM REGENT
- 2023STERILE WATER FOR INJECTIONGeneric (ANDA)
ANDA 217536 · NEXUS
- 2023STERILE WATER FOR INJECTIONGeneric (ANDA)
ANDA 212735 · HIKMA
- 2021STERILE WATER FOR INJECTIONGeneric (ANDA)
ANDA 211222 · NEPHRON
- 2019STERILE WATER FOR INJECTIONGeneric (ANDA)
ANDA 211188 · MEDEFIL INC
- 2017STERILE WATER FOR INJECTIONGeneric (ANDA)
ANDA 209689 · 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.
