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PIPERACILLIN AND TAZOBACTAM

ANDA

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | A065386 | HOSPIRA INC

3 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Sep 22, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 15, 2009

No patent or exclusivity listings for this strength.

#002 — EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 15, 2009

#003 — EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 15, 2009