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Serving leading biopharmaceutical companies globally:

McKesson
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Fuji
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Cerilliant
Cipla
McKinsey
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065176

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NDA 065176 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 eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 065176
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Hanford Gc
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065176
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065176 ANDA WG Critical Care, LLC 44567-210 44567-210-10 10 VIAL in 1 CARTON (44567-210-10) > 20 mL in 1 VIAL
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065176 ANDA WG Critical Care, LLC 44567-211 44567-211-10 10 VIAL in 1 CARTON (44567-211-10) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Nov 30, 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 30, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
AstraZeneca
Boehringer Ingelheim
Baxter
Johnson and Johnson
Mallinckrodt
Cantor Fitzgerald
Harvard Business School
Julphar

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