Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065323
Company: SUN PHARM INDS LTD

Products on ANDA 065323

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2008	ORIG-1	Approval				Label is not available on this site.