Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021734
Company: SUN PHARMA CANADA

Products on NDA 21734

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

Labels for NDA 021734

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021734lbl.pdf