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Details for New Drug Application (NDA): 050813

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NDA 050813 describes MOXATAG, which is a drug marketed by Vernalis R And D Ltd and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the MOXATAG profile page.

The generic ingredient in MOXATAG is amoxicillin. There are forty-three drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

Summary for NDA: 050813

Tradename:
MOXATAG
Applicant:
Vernalis R And D Ltd
Ingredient:
amoxicillin
Patents:6
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050813

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 050813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOXATAG
amoxicillin
TABLET, EXTENDED RELEASE;ORAL 050813 NDA Vernalis Therapeutics, Inc. 69442-030 69442-030-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69442-030-01)
MOXATAG
amoxicillin
TABLET, EXTENDED RELEASE;ORAL 050813 NDA Vernalis Therapeutics, Inc. 69442-030 69442-030-10 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69442-030-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength775MG
Approval Date:Jan 23, 2008TE:RLD:Yes
Patent:8,357,394Patent Expiration:Dec 8, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:6,544,555Patent Expiration:Oct 13, 2020Product 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
Patent:6,669,948Patent Expiration:Oct 13, 2020Product 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


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