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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 050785

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NDA 050785 describes AUGMENTIN XR, which is a drug marketed by Us Antibiotics and is included in one NDA. Additional details are available on the AUGMENTIN XR profile page.

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

Summary for 050785

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM;EQ 62.5MG BASE
Approval Date:	Sep 25, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 050785

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	⤷ Try a Trial	⤷ Try a Trial
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	⤷ Try a Trial	⤷ Try a Trial
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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