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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 065310


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NDA 065310 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, Pharm Assoc, Sandoz, and Steriscience, 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 seventy 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 065310
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Sandoz
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0
Pharmacology for NDA: 065310
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065310
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065310 ANDA Hospira, Inc 0409-2689 0409-2689-01 10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065310 ANDA Hospira, Inc 0409-2987 0409-2987-03 10 VIAL in 1 TRAY (0409-2987-03) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2987-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Jul 25, 2006TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Jul 25, 2006TE:APRLD:No

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