Orange Book product · Brand (NDA)
STERILE WATER
STERILE WATER FOR IRRIGATION
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
STERILE WATER FOR IRRIGATION
Strength
100%
Dosage form
LIQUID
Route
IRRIGATION
TE code
AT
Application
NDA 017428
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —STERILE WATER IN PLASTIC CONTAINERBrand (NDA)
NDA 016734 · B BRAUN
- —STERILE WATER IN PLASTIC CONTAINERBrand (NDA)
NDA 017866 · BAXTER HLTHCARE
- —STERILE WATER IN PLASTIC CONTAINERBrand (NDA)
NDA 018246 · MILES
- —STERILE WATER IN PLASTIC CONTAINERBrand (NDA)
NDA 017513 · OTSUKA ICU MEDCL
- —STERILE WATER IN PLASTIC CONTAINERBrand (NDA)
NDA 018313 · OTSUKA ICU MEDCL
- 2024STERILE WATER FOR IRRIGATIONGeneric (ANDA)
ANDA 216123 · 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.
