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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, Antibiotics Sa, Sandoz, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Aurobindo Pharma, Hospira Inc, Eurohlth Intl Sarl, Hanford Gc, and Sagent Pharms, and is included in twenty-three NDAs. It is available from thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.

Summary for NDA: 090375

Tradename:
AMPICILLIN AND SULBACTAM
Applicant:
Hospira Inc
Ingredient:
ampicillin sodium; sulbactam sodium
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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