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US Department of Justice
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065188

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NDA 065188 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Aurobindo Pharma, Hanford Gc, Hospira Inc, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, and West-ward Pharms Int, and is included in twenty-three NDAs. It is available from ten suppliers. Additional details are available on the AMPICILLIN AND SULBACTAM profile page.

The generic ingredient in AMPICILLIN AND SULBACTAM is ampicillin sodium; sulbactam sodium. There are sixty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 065188
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Hanford Gc
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065188
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065188
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065188 ANDA WG Critical Care, LLC 44567-212 N 44567-212-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date:Nov 25, 2005TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Covington
Julphar
Cipla
US Army
Deloitte
AstraZeneca
Healthtrust

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