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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 21, 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 Bio Ag, Apothecon, Sandoz Inc, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in seventy-five NDAs. It is available from thirty-six suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-five drug master file entries for this compound. Thirty-seven 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-type	Penicillins

Medical Subject Heading (MeSH) Categories for 062881

Anti-Bacterial Agents

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	N	35356-985-21
AMOXICILLIN	amoxicillin	CAPSULE;ORAL	062881	ANDA	Lake Erie Medical DBA Quality Care Products LLC	35356-985	N	35356-985-30

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Feb 25, 1988	TE:	AB	RLD:	No

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