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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050575

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NDA 050575 describes AUGMENTIN '250', which is a drug marketed by Dr Reddys Labs Inc and is included in three NDAs. It is available from four suppliers. Additional details are available on the AUGMENTIN '250' profile page.

The generic ingredient in AUGMENTIN '250' 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 050575
Tradename:AUGMENTIN '250'
Applicant:Dr Reddys Labs Inc
Ingredient:amoxicillin; clavulanate potassium
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050575
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050575
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN '125' amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050575 NDA Rebel Distributors Corp 42254-282 E 42254-282-00
AUGMENTIN '125' amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050575 NDA Dr. Reddy's Laboratories Inc 43598-004 N 43598-004-51

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML;EQ 31.25MG BASE/5ML
Approval Date:Aug 6, 1984TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date:Aug 6, 1984TE:ABRLD:Yes

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