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Serving leading biopharmaceutical companies globally:

Healthtrust
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062881

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NDA 062881 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. Fifty suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 062881
Tradename:AMOXICILLIN
Applicant:Dava Pharms Inc
Ingredient:amoxicillin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062881
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 062881
Suppliers and Packaging for NDA: 062881
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin CAPSULE;ORAL 062881 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-985 35356-985-30 30 CAPSULE in 1 BOTTLE (35356-985-30)
AMOXICILLIN amoxicillin CAPSULE;ORAL 062881 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-985 35356-985-40 40 CAPSULE in 1 BOTTLE (35356-985-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Feb 25, 1988TE:ABRLD:No

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Covington
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