Details for New Drug Application (NDA): 050608

NDA 050608 describes UNASYN, which is a drug marketed by Pfizer and is included in two NDAs. It is available from one supplier. Additional details are available on the UNASYN profile page.

The generic ingredient in UNASYN 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 050608

Tradename:	UNASYN
Applicant:	Pfizer
Ingredient:	ampicillin sodium; sulbactam sodium
Patents:	0

Pharmacology for NDA: 050608

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050608

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0013	0049-0013-83	10 VIAL in 1 CARTON (0049-0013-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81)
UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0014	0049-0014-83	10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:	Dec 31, 1986	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:	Dec 31, 1986	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:	Dec 31, 1986	TE:		RLD:	No

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