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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 065314


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NDA 065314 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Medimetriks Pharms, Onesource Specialty, and Sandoz, and is included in twenty-three NDAs. It is available from twelve 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 seventy drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 065314
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Istituto Bio Ita Spa
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0
Pharmacology for NDA: 065314
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065314
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065314 ANDA Meitheal Pharmaceuticals Inc. 71288-033 71288-033-75 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065314 ANDA Meitheal Pharmaceuticals Inc. 71288-033 71288-033-91 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date:Nov 27, 2006TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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