Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050459
Company: GLAXOSMITHKLINE

Products on NDA 050459

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXIL	AMOXICILLIN	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
AMOXIL	AMOXICILLIN	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050459

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/1974	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.