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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Colorcon
Baxter
Deloitte
Boehringer Ingelheim
Healthtrust
Fish and Richardson
QuintilesIMS
Dow

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090375

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NDA 090375 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Sandoz, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Aurobindo Pharma, Hospira Inc, West-ward Pharms Int, Hanford Gc, and Sagent Pharms, 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 sixty-nine 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 NDA: 090375

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090375

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 090375

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 090375 ANDA Hospira, Inc. 0409-2988 0409-2988-15 10 VIAL in 1 CARTON (0409-2988-15) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN AND SULBACTAM
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 090375 ANDA Hospira, Inc. 0409-2988 0409-2988-10 10 BOTTLE in 1 CARTON (0409-2988-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Dec 21, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Dec 21, 2011TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Healthtrust
Cerilliant
QuintilesIMS
Citi
Chubb
US Army
Argus Health
Harvard Business School

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