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Cantor Fitzgerald
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Harvard Business School
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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065222

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NDA 065222 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 065222
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Istituto Bio Ita Spa
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065222
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065222 ANDA APP Pharmaceuticals, LLC 63323-368 E 63323-368-20
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065222 ANDA APP Pharmaceuticals, LLC 63323-369 E 63323-369-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Nov 29, 2005TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Nov 29, 2005TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Mallinckrodt
Medtronic
Merck
Fish and Richardson
Covington
Dow
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