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ZOSYN IN PLASTIC CONTAINER

NDA

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | N050750 | BAXTER HEALTHCARE CORP

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs5 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

YUHAN CHEMICAL INCPIPERACILLIN MONOHYDRATE

DMF 168412003

SANDOZ INDUSTRIAL PRODUCTS SAPIPERACILLIN

DMF 181612005

APITORIA PHARMA PRIVATE LTDPIPERACILLIN USP

DMF 192652006

SHANDONG RUIYING PIONEER PHARMACEUTICAL CO LTDPIPERACILLIN

DMF 236142010

SHANDONG ANXIN PHARMACEUTICAL CO LTDPIPERACILLIN (NON-STERILE API)

DMF 259042012

JIANGXI FUSHINE PHARMACEUTICAL CO LTDPIPERACILLIN

DMF 324832018

SHANDONG ANXIN PHARMACEUTICAL CO LTDPIPERACILLIN USP (NON-STERILE API)

DMF 337862019

SHANDONG ANSHUN PHARMACEUTICAL CO LTDPIPERACILLIN (NON-STERILE API)

DMF 339802019

INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO LTDPIPERACILLIN

DMF 358252021

LEDERLE LABORATORIES DIV AMERICAN CYANAMID COInactivePIPERACILLIN MONOHYDRATE

DMF 101121980

BRISTOL MYERS SQUIBB COInactivePIPERACILLIN MONOHYDRATE

DMF 101331982

CORDEN PHARMA LATINA SPAInactivePIPERACILLIN MONOHYDRATE

DMF 128291998

PFIZER HEALTHCARE INDIA PVT LTDInactivePIPERACILLIN

DMF 190312005

QILU PHARMACEUTICAL CO LTDInactivePIPERACILLIN (NON STERILE BULK FORM)

DMF 204312007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

30 letters from Drugs@FDA

Date	Submission	Document
Dec 4, 2024	SUPPL -53	View Letter (PDF)
Nov 21, 2024	SUPPL -54	View Letter (PDF)
May 2, 2024	SUPPL -50	View Letter (PDF)
May 2, 2024	SUPPL -51	View Letter (PDF)
Dec 20, 2022	SUPPL -49	View Letter (PDF)
Apr 11, 2022	SUPPL -47	View Letter (PDF)
Mar 24, 2022	SUPPL -48	View Letter (PDF)
Aug 2, 2021	SUPPL -45	View Letter (PDF)
May 28, 2020	SUPPL -43	View Letter (PDF)
Apr 14, 2020	SUPPL -42	View Letter (PDF)
May 14, 2019	SUPPL -41	View Letter (PDF)
May 9, 2017	SUPPL -37	View Letter (PDF)
May 9, 2017	SUPPL -39	View Letter (PDF)
May 9, 2017	SUPPL -38	View Letter (PDF)
Jun 13, 2016	SUPPL -34	View Letter (PDF)
Jun 13, 2016	SUPPL -35	View Letter (PDF)
Dec 22, 2015	SUPPL -33	View Letter (PDF)
Sep 11, 2013	SUPPL -30	View Letter (PDF)
Sep 11, 2013	SUPPL -21	View Letter (PDF)
Sep 11, 2013	SUPPL -26	View Letter (PDF)
May 15, 2012	SUPPL -16	View Letter (PDF)
Oct 3, 2011	SUPPL -24	View Letter (PDF)
Apr 22, 2008	SUPPL -15	View Letter (PDF)
Aug 4, 2006	SUPPL -14	View Letter (PDF)
Oct 20, 2005	SUPPL -12	View Letter (PDF)
Jun 29, 2005	SUPPL -11	View Letter (PDF)
Mar 18, 2005	SUPPL -9	View Letter (PDF)
May 30, 2003	SUPPL -7	View Letter (PDF)
May 30, 2003	SUPPL -8	View Letter (PDF)
Mar 27, 2002	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 40MG BASE/ML;EQ 5MG BASE/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 24, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 60MG BASE/ML;EQ 7.5MG BASE/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 24, 1998

#003 — EQ 4GM BASE/100ML;EQ 500MG BASE/100ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 24, 1998