Orange Book product · Brand (NDA)
ZOSYN
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
At a glance
Oct 22, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 22, 1993
33 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Strength
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050684
Product number
004
Marketing status
DISCN
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.
- 2025PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERBrand (NDA)
NDA 206056 · B BRAUN MEDICAL
- 1998ZOSYN IN PLASTIC CONTAINERBrand (NDA)
NDA 050750 · BAXTER HLTHCARE CORP
- 2023PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 217409 · EUGIA PHARMA
- 2023PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 217243 · SHANDONG
- 2021PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 208674 · SAGENT PHARMS INC
- 2021PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 208675 · SAGENT PHARMS INC
- 2019PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 212287 · ASTRAL
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 204959 · SHANDONG
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 203719 · FRESENIUS KABI
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 203720 · FRESENIUS KABI
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 206204 · FRESENIUS KABI USA
- 2017PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 206996 · APOTEX
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.
