FDA Orange Book · active-ingredient family
Sterile water for injection
Sterile water for injection is approved as 7 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:STERILE WATER FOR INJECTION IN PLASTIC CONTAINER · NDA 019869
7
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · liquid
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 019869 | AP | Dec 26, 1989 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINERRLD | B BRAUN | NDA 019633 | AP | Feb 29, 1988 | |
| BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 018802 | AP | Oct 27, 1982 | |
| STERILE WATER FOR INJECTIONRLD×6 | HOSPIRA | NDA 018801 | — | Oct 27, 1982 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINERRLD×2 | BAXTER HLTHCARE | NDA 018632 | AP | Jun 30, 1982 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 018233 | AP | Approved Prior to Jan 1, 1982 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | B BRAUN | NDA 019077 | — | Mar 02, 1984 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION×3 | AM REGENT | ANDA 217341 | AP | Aug 29, 2023 | |
| STERILE WATER FOR INJECTION×2 | NEXUS | ANDA 217536 | AP | Jul 11, 2023 | |
| STERILE WATER FOR INJECTION | HIKMA | ANDA 212735 | AP | Jan 31, 2023 | |
| STERILE WATER FOR INJECTION | NEPHRON | ANDA 211222 | AP | Feb 10, 2021 | |
| STERILE WATER FOR INJECTION×5 | MEDEFIL INC | ANDA 211188 | — | Dec 02, 2019 | |
| STERILE WATER FOR INJECTION | FRESENIUS KABI USA | ANDA 209689 | AP | Nov 24, 2017 | |
| STERILE WATER FOR INJECTION×2 | HIKMA | ANDA 206369 | AP | Sep 02, 2015 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | TARO | ANDA 077393 | — | Aug 11, 2006 | |
| BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER | ABRAXIS PHARM | ANDA 089099 | — | Dec 29, 1987 | |
| BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER | ABRAXIS PHARM | ANDA 089100 | — | Dec 29, 1987 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 088400 | AP | Jan 16, 1984 |
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 injection — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
