Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021165
Company: ORGANON
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf | |
| 12/22/2010 | SUPPL-14 | Labeling-Patient 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 |