Details for New Drug Application (NDA): 050575

NDA 050575 describes AUGMENTIN '250', which is a drug marketed by Us Antibiotics and is included in three NDAs. It is available from three suppliers. Additional details are available on the AUGMENTIN '250' profile page.

The generic ingredient in AUGMENTIN '250' is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 050575

Tradename:	AUGMENTIN '250'
Applicant:	Us Antibiotics
Ingredient:	amoxicillin; clavulanate potassium
Patents:	0

Pharmacology for NDA: 050575

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050575

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AUGMENTIN '125'	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050575	NDA	Allegis Pharmaceuticals, LLC	28595-240	28595-240-35	100 mL in 1 BOTTLE (28595-240-35)
AUGMENTIN '125'	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050575	NDA	Allegis Pharmaceuticals, LLC	28595-240	28595-240-36	150 mL in 1 BOTTLE (28595-240-36)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	125MG/5ML;EQ 31.25MG BASE/5ML
Approval Date:	Aug 6, 1984	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date:	Aug 6, 1984	TE:	AB	RLD:	Yes

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