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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 fifty-two suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Forty-five 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
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	Northwind Pharmaceuticals	51655-157	51655-157-21	21 CAPSULE in 1 BOTTLE, DISPENSING (51655-157-21)
AMOXICILLIN	amoxicillin	CAPSULE;ORAL	062881	ANDA	Lake Erie Medical DBA Quality Care Products LLC	55700-207	55700-207-30	30 CAPSULE in 1 BOTTLE (55700-207-30)

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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