Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076529
Company: RANBAXY LABS LTD

Products on ANDA 076529

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE	LORATADINE	1MG/ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076529

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2004	ORIG-1	Approval				Label is not available on this site.