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Details for New Drug Application (NDA): 065458

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NDA 065458 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Istituto Bio Ita Spa, Hospira Inc, Apollo Pharms Inc, Sandoz Inc, Mylan Labs Ltd, Sandoz, and Aurobindo Pharma Ltd, and is included in eleven NDAs. It is available from ten 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 fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for NDA: 065458

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065458

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 065458 ANDA Mylan Institutional LLC 67457-521 67457-521-22 10 VIAL, SINGLE-USE in 1 CARTON (67457-521-22) > 10 mL in 1 VIAL, SINGLE-USE (67457-521-00)
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 065458 ANDA Mylan Institutional LLC 67457-522 67457-522-37 10 VIAL, SINGLE-USE in 1 CARTON (67457-522-37) > 15 mL in 1 VIAL, SINGLE-USE (67457-522-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Aug 15, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date:Aug 15, 2014TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Aug 15, 2014TE:APRLD:No


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