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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 050813

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NDA 050813 describes MOXATAG, which is a drug marketed by Pragma and is included in one NDA. There are three patents protecting this drug. Additional details are available on the MOXATAG profile page.

The generic ingredient in MOXATAG is amoxicillin. 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 profile page.

Summary for 050813

Tradename:	MOXATAG
Applicant:	Pragma
Ingredient:	amoxicillin
Patents:	3

Medical Subject Heading (MeSH) Categories for 050813

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	775MG
Approval Date:	Jan 23, 2008	TE:		RLD:	Yes
Patent:	8,299,052	Patent Expiration:	May 7, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF ONCE-A-DAY AMOXICILLIN PRODUCT TO TREAT TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES
Patent:	8,357,394	Patent Expiration:	Dec 8, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,778,924	Patent Expiration:	Dec 8, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT

Expired US Patents for NDA 050813

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,544,555	⤷ Get Started Free
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,723,341	⤷ Get Started Free
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,669,948	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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