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Generated: September 24, 2018

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Details for New Drug Application (NDA): 065362

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NDA 065362 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. Fifteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 065362
Pharmacology for NDA: 065362
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065362 ANDA Hospira, Inc 0409-3383 0409-3383-02 10 VIAL, SINGLE-USE in 1 CARTON (0409-3383-02) > 10 mL in 1 VIAL, SINGLE-USE
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065362 ANDA Hospira, Inc 0409-3385 0409-3385-13 10 VIAL, SINGLE-USE in 1 CARTON (0409-3385-13) > 15 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Oct 21, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date:Oct 21, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Oct 21, 2010TE:APRLD:No

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