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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Johnson and Johnson
Moodys
Healthtrust
McKesson
AstraZeneca
Queensland Health
Accenture
Novartis

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065387

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NDA 065387 describes AMOXICILLIN, which is a drug marketed by Am Antibiotics, Aurobindo, Dava Pharms Inc, Hikma Pharms, Labs Atral, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Hikma, Wockhardt, Apothecon, Sandoz Inc, Wockhardt Eu Operatn, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in seventy-five NDAs. It is available from fifty-four suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN 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 065387

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

Pharmacology for NDA: 065387

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 065387

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065387 ANDA Sandoz Inc 0781-6039 0781-6039-55 150 mL in 1 BOTTLE (0781-6039-55)
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065387 ANDA Sandoz Inc 0781-6039 0781-6039-46 100 mL in 1 BOTTLE (0781-6039-46)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Mar 26, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Mar 26, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Chubb
Argus Health
Teva
Harvard Business School
Johnson and Johnson
US Army
Merck
Mallinckrodt
Express Scripts
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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