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Generated: May 24, 2017

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Details for New Drug Application (NDA): 050755

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NDA 050755 describes AUGMENTIN ES-600, which is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. It is available from five suppliers. Additional details are available on the AUGMENTIN ES-600 profile page.

The generic ingredient in AUGMENTIN ES-600 is amoxicillin; clavulanate potassium. There are forty-four drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for NDA: 050755

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050755

Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050755

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 050755 NDA Aidarex Pharmaceuticals LLC 33261-600 33261-600-01 75 mL in 1 BOTTLE, PLASTIC (33261-600-01)
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 050755 NDA Aidarex Pharmaceuticals LLC 33261-970 33261-970-01 200 mL in 1 BOTTLE, PLASTIC (33261-970-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Jun 22, 2001TE:RLD:Yes

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