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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050785

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NDA 050785 describes AUGMENTIN XR, which is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AUGMENTIN XR profile page.

The generic ingredient in AUGMENTIN XR is amoxicillin; clavulanate potassium. There are forty-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 050785
Tradename:AUGMENTIN XR
Applicant:Dr Reddys Labs Inc
Ingredient:amoxicillin; clavulanate potassium
Patents:5
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050785
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050785
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785 NDA Dr Reddys Laboratories Inc 43598-020 N 43598-020-28
AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785 NDA Dr Reddys Laboratories Inc 43598-020 N 43598-020-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;EQ 62.5MG BASE
Approval Date:Sep 25, 2002TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 4, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)

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