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Details for New Drug Application (NDA): 065240

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NDA 065240 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, West-ward Pharms Int, 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: 065240

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065240

Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065240

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 065240 ANDA Hospira, Inc 0409-2687 0409-2687-15 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-2687-15)
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 065240 ANDA Hospira, Inc 0409-2687 0409-2687-05 1 VIAL in 1 CARTON (0409-2687-05) > 100 mL in 1 VIAL

Summary for product number 001

Approval Date:Jul 25, 2006TE:APRLD:No

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