Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021165
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARINEX DESLORATADINE 5MG TABLET;ORAL Prescription AB 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
12/21/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-165_Clarinex_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-165_Clarinex.cfm
Supplements
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)
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-20 Labeling-Package Insert, 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
06/16/2016 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/16/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/23/2014 SUPPL-17 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
07/23/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/22/2010 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf
12/14/2006 SUPPL-9 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-8 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-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf
01/29/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr006ltr.pdf
02/08/2002 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21165s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex.cfm
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

CLARINEX

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX DESLORATADINE 5MG TABLET;ORAL Prescription Yes AB 021165 MERCK SHARP DOHME
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078355 BELCHER PHARMS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078365 DR REDDYS LABS LTD
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078352 LUPIN PHARMS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078357 ORCHID HLTHCARE
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078361 PERRIGO
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078364 SANDOZ
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078359 SUN PHARM INDS

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