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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090227

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NDA 090227 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt, Wockhardt Eu Operatn, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from forty-four suppliers. Additional details are available on the AMOXICILLIN AND CLAVULANATE POTASSIUM profile page.

The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-four drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 090227

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090227

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 090227

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 090227 ANDA Sandoz Inc 0781-1943 0781-1943-39 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 090227 ANDA Sandoz Inc 0781-1943 0781-1943-82 28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;EQ 62.5MG BASE
Approval Date:Apr 21, 2010TE:ABRLD:No


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