Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021300
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARINEX DESLORATADINE 0.5MG/ML SOLUTION;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/01/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21300lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21300ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021300s000_ClarinexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2019 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s022,021300s019,021312s020,021563s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021165Orig1s022, 021300Orig1s019, 021312Orig1s020, 021563Orig1s008, 021313Orig1s012, 021605Orig1s017ltr.pdf
03/01/2019 SUPPL-17 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s020,021300s017,021312s018,021563s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021165Orig1s020, 021300Orig1s017, 021312Orig1s018, 021563Orig1s006ltr.pdf
04/23/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf
12/22/2010 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf
12/14/2006 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf
12/14/2006 SUPPL-4 Labeling

Label is not available on this site.

12/14/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf
12/14/2006 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/15/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s022,021300s019,021312s020,021563s008lbl.pdf
03/01/2019 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s020,021300s017,021312s018,021563s006lbl.pdf
04/23/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf
09/01/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21300lbl.pdf

CLARINEX

SOLUTION;ORAL; 0.5MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX DESLORATADINE 0.5MG/ML SOLUTION;ORAL Prescription Yes AA 021300 MERCK SHARP DOHME
DESLORATADINE DESLORATADINE 0.5MG/ML SOLUTION;ORAL Prescription No AA 202936 TARO
DESLORATADINE DESLORATADINE 0.5MG/ML SOLUTION;ORAL Prescription No AA 202592 TARO PHARM INDS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English