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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 065316

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NDA 065316 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, Onesource Specialty, and Sandoz, 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 seventy 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 065316

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:	Jun 29, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:	Jun 29, 2007	TE:		RLD:	No

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