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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065386

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NDA 065386 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Istituto Bio Ita Spa, Hospira Inc, Wockhardt Bio Ag, Apollo Pharms Inc, Sandoz Inc, Mylan Labs Ltd, Sandoz, and Aurobindo Pharma Ltd, and is included in thirteen NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for NDA: 065386

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

Pharmacology for NDA: 065386

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065386

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 065386 ANDA Apotex Corporation 60505-0686 60505-0686-4 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-0686-4) > 10 mL in 1 VIAL, SINGLE-DOSE (60505-0686-1)
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 065386 ANDA Apotex Corporation 60505-0687 60505-0687-4 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-0687-4) > 15 mL in 1 VIAL, SINGLE-DOSE (60505-0687-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Sep 15, 2009TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date:Sep 15, 2009TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Sep 15, 2009TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Teva
McKinsey
Julphar
Deloitte
Novartis
Baxter
Farmers Insurance
AstraZeneca
Cerilliant

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