FDA Orange Book · active-ingredient family
Piperacillin sodium; tazobactam sodium
Piperacillin sodium; tazobactam sodium is approved as 3 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER · NDA 206056
3
Brand (NDA)
22
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERRLD×3 | B BRAUN MEDICAL | NDA 206056 | — | Apr 03, 2025 | |
| ZOSYN IN PLASTIC CONTAINERRLD×3 | BAXTER HLTHCARE CORP | NDA 050750 | — | Feb 24, 1998 | |
| ZOSYNRLD×4 | WYETH PHARMS | NDA 050684 | — | Oct 22, 1993 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM×2 | EUGIA PHARMA | ANDA 217409 | — | Oct 12, 2023 | |
| PIPERACILLIN AND TAZOBACTAM | SHANDONG | ANDA 217243 | AP | Apr 14, 2023 | |
| PIPERACILLIN AND TAZOBACTAM×3 | SAGENT PHARMS INC | ANDA 208674 | AP | Feb 16, 2021 | |
| PIPERACILLIN AND TAZOBACTAM | SAGENT PHARMS INC | ANDA 208675 | AP | Feb 16, 2021 | |
| PIPERACILLIN AND TAZOBACTAM×3 | ASTRAL | ANDA 212287 | — | Jul 29, 2019 | |
| PIPERACILLIN AND TAZOBACTAM×3 | SHANDONG | ANDA 204959 | AP | Aug 10, 2018 | |
| PIPERACILLIN AND TAZOBACTAM×3 | FRESENIUS KABI | ANDA 203719 | AP | May 18, 2018 | |
| PIPERACILLIN AND TAZOBACTAM | FRESENIUS KABI | ANDA 203720 | AP | May 11, 2018 | |
| PIPERACILLIN AND TAZOBACTAM | FRESENIUS KABI USA | ANDA 206204 | — | May 11, 2018 | |
| PIPERACILLIN AND TAZOBACTAM×3 | APOTEX | ANDA 206996 | AP | Mar 22, 2017 | |
| PIPERACILLIN AND TAZOBACTAM | APOTEX | ANDA 207146 | AP | Mar 17, 2017 | |
| PIPERACILLIN AND TAZOBACTAM×3 | MILLA PHARMS | ANDA 207847 | AP | Jan 13, 2017 | |
| PIPERACILLIN AND TAZOBACTAM×2 | MILLA PHARMS | ANDA 207848 | AP | Jan 13, 2017 | |
| PIPERACILLIN AND TAZOBACTAM×2 | SANDOZ | ANDA 203557 | AP | Oct 29, 2014 | |
| PIPERACILLIN AND TAZOBACTAM×3 | ONESOURCE SPECIALTY | ANDA 065458 | AP | Aug 15, 2014 | |
| PIPERACILLIN AND TAZOBACTAM×3 | ISTITUTO BIO ITA SPA | ANDA 065523 | AP | May 31, 2011 | |
| PIPERACILLIN AND TAZOBACTAM | ISTITUTO BIO ITA SPA | ANDA 090498 | AP | May 31, 2011 | |
| PIPERACILLIN AND TAZOBACTAM×3 | EUGIA PHARMA SPECLTS | ANDA 065498 | AP | May 23, 2011 | |
| PIPERACILLIN AND TAZOBACTAM×3 | SANDOZ | ANDA 065362 | AP | Oct 21, 2010 | |
| PIPERACILLIN AND TAZOBACTAM×3 | SANDOZ | ANDA 065363 | — | Oct 21, 2010 | |
| PIPERACILLIN AND TAZOBACTAM×3 | HOSPIRA INC | ANDA 065386 | — | Sep 15, 2009 | |
| PIPERACILLIN AND TAZOBACTAM | HOSPIRA INC | ANDA 065446 | — | Sep 15, 2009 |
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.
Piperacillin sodium; tazobactam sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
