Details for New Drug Application (NDA): 050725

NDA 050725 describes AUGMENTIN '400', which is a drug marketed by Us Antibiotics and is included in two NDAs. It is available from one supplier. Additional details are available on the AUGMENTIN '400' profile page.

The generic ingredient in AUGMENTIN '400' is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 050725

Tradename:	AUGMENTIN '400'
Applicant:	Us Antibiotics
Ingredient:	amoxicillin; clavulanate potassium
Patents:	0

Pharmacology for NDA: 050725

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050725

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AUGMENTIN '200'	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050725	NDA	Proficient Rx LP	63187-320	63187-320-00	100 mL in 1 BOTTLE (63187-320-00)
AUGMENTIN '400'	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050725	NDA	Proficient Rx LP	63187-320	63187-320-00	100 mL in 1 BOTTLE (63187-320-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date:	May 31, 1996	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	400MG/5ML;EQ 57MG BASE/5ML
Approval Date:	May 31, 1996	TE:		RLD:	Yes

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