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Serving 500+ biopharmaceutical companies globally:

Deloitte
Merck
AstraZeneca
Teva
Chubb
Dow
Medtronic
Accenture
McKesson
Colorcon

Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065325

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NDA 065325 describes AMOXICILLIN, which is a drug marketed by Teva, Sun Pharm Inds Ltd, Wockhardt, Hikma, Aurobindo Pharma Ltd, Dava Pharms Inc, Labs Atral, Sandoz, Apothecon, Aurobindo, Am Antibiotics, Mylan, Hikma Pharms, Micro Labs Ltd India, Apotex Inc, Sandoz Inc, Wockhardt Eu Operatn, 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-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for NDA: 065325

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

Pharmacology for NDA: 065325

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 065325

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN
amoxicillin
FOR SUSPENSION;ORAL 065325 ANDA West-Ward Pharmaceuticals Corp 0143-9886 0143-9886-01 100 mL in 1 BOTTLE (0143-9886-01)
AMOXICILLIN
amoxicillin
FOR SUSPENSION;ORAL 065325 ANDA West-Ward Pharmaceuticals Corp 0143-9886 0143-9886-50 50 mL in 1 BOTTLE (0143-9886-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML
Approval Date:Jun 19, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Jun 19, 2006TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Queensland Health
Deloitte
QuintilesIMS
Chinese Patent Office
Argus Health
Daiichi Sankyo
Baxter
Mallinckrodt

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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