Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050460
Company: GLAXOSMITHKLINE

Products on NDA 050460

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXIL	AMOXICILLIN	125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
AMOXIL	AMOXICILLIN	250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
AMOXIL	AMOXICILLIN	50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
LAROTID	AMOXICILLIN	50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050460

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 3 - New Dosage Form	PRIORITY		Label is not available on this site.