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Generated: December 18, 2017

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Details for New Drug Application (NDA): 201024

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NDA 201024 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Aurobindo Pharma, Hanford Gc, Hospira Inc, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, and West-ward Pharms Int, 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 201024

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

Pharmacology for NDA: 201024

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 201024

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 201024 ANDA Mylan Institutional LLC 67457-348 67457-348-15 1 VIAL in 1 CARTON (67457-348-15) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 201024 ANDA Mylan Institutional LLC 67457-349 67457-349-10 10 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (67457-349-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Apr 7, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Apr 7, 2014TE:APRLD:No


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