FDA Orange Book · active-ingredient family
Sterile water for irrigation
Sterile water for irrigation is approved as 6 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:STERILE WATER · NDA 017428
6
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · liquid
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STERILE WATERRLD | BAXTER HLTHCARE | NDA 017428 | AT | Approved Prior to Jan 1, 1982 | |
| STERILE WATER IN PLASTIC CONTAINERRLD | B BRAUN | NDA 016734 | AT | Approved Prior to Jan 1, 1982 | |
| STERILE WATER IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 017866 | AT | Approved Prior to Jan 1, 1982 | |
| STERILE WATER IN PLASTIC CONTAINER | MILES | NDA 018246 | — | Approved Prior to Jan 1, 1982 | |
| STERILE WATER IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 017513 | AT | Approved Prior to Jan 1, 1982 | |
| STERILE WATER IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 018313 | AT | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STERILE WATER FOR IRRIGATION | FRESENIUS KABI USA | ANDA 216123 | AT | Aug 12, 2024 |
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.
Sterile water for irrigation — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
