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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201406


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NDA 201406 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, Medimetriks Pharms, Sandoz, and Steriscience Speclts, 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 seventy 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 201406
Pharmacology for NDA: 201406
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 201406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 201406 ANDA WG Critical Care, LLC 44567-150 44567-150-10 10 VIAL in 1 CARTON (44567-150-10) / 20 mL in 1 VIAL
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 201406 ANDA Methapharm, Inc. 67850-130 67850-130-10 10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Dec 7, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Dec 7, 2015TE:APRLD:No

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