Details for New Drug Application (NDA): 201406

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

Tradename:	AMPICILLIN AND SULBACTAM
Applicant:	Antibiotice
Ingredient:	ampicillin sodium; sulbactam sodium
Patents:	0

Pharmacology for NDA: 201406

Mechanism of Action

beta 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:	Dec 7, 2015	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:	Dec 7, 2015	TE:	AP	RLD:	No

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