Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021165
Company: ORGANON

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARINEX DESLORATADINE 5MG TABLET;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/15/2019 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s022,021300s019,021312s020,021563s008lbl.pdf
03/01/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s020,021300s017,021312s018,021563s006lbl.pdf
03/01/2019 SUPPL-20 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s020,021300s017,021312s018,021563s006lbl.pdf
04/23/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf
12/22/2010 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf
12/22/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf
02/08/2002 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex_Prntlbl.pdf
12/21/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21165lbl.pdf

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