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Serving leading biopharmaceutical companies globally:

Teva
US Army
Chubb
Chinese Patent Office
McKesson
McKinsey
Mallinckrodt
QuintilesIMS
Boehringer Ingelheim
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090578

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NDA 090578 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 nine 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. Ten suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 090578
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Sagent Pharms
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090578
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 090578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 090578 ANDA Sagent Pharmaceuticals 25021-188 N 25021-188-99

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date:Jan 11, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Fuji
Baxter
Cantor Fitzgerald
Medtronic
Covington
Deloitte
Cipla

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