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Generated: November 21, 2018

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Details for New Drug Application (NDA): 207146

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NDA 207146 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Apollo Pharms Inc, Aurobindo Pharma Ltd, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Qilu Tianhe, Sandoz, Sandoz Inc, and Wockhardt Bio Ag, and is included in seventeen NDAs. It is available from thirteen suppliers. Additional details are available on the PIPERACILLIN AND TAZOBACTAM profile page.

The generic ingredient in PIPERACILLIN AND TAZOBACTAM is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 207146
Pharmacology for NDA: 207146
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 207146
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 207146 ANDA Mitim S.r.l. 22607-679 22607-679-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (22607-679-01) > 180 mL in 1 VIAL, PHARMACY BULK PACKAGE (22607-679-02)
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 207146 ANDA Wockhardt USA LLC. 64679-679 64679-679-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (64679-679-01) > 180 mL in 1 VIAL, PHARMACY BULK PACKAGE (64679-679-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:Mar 17, 2017TE:APRLD:No

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