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Last Updated: March 29, 2024

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-five 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 050813

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength775MG
Approval Date:Jan 23, 2008TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:May 7, 2027Product 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:⤷  Try a TrialPatent Expiration:Dec 8, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 8, 2026Product Flag?YSubstance Flag?YDelist 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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