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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021312
Company: ORGANON

Products on NDA 021312

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARINEX	DESLORATADINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
CLARINEX	DESLORATADINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021312

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21312ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-312_Clarinex.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2019	SUPPL-20	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-18	Labeling-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-15	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
11/14/2012	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/22/2010	SUPPL-11	Labeling-Patient Package Insert, Labeling-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-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
07/14/2005	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021312s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021312s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021312_s007_clarinex red-tabs.pdf
12/14/2006	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021312s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf
01/29/2004	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr006ltr.pdf
02/06/2003	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21312slr002ltr.pdf

Labels for NDA 021312

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s022,021300s019,021312s020,021563s008lbl.pdf
03/01/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021165s020,021300s017,021312s018,021563s006lbl.pdf
04/23/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf
12/14/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021312s006lbl.pdf
07/14/2005	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021312s007lbl.pdf
06/26/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21312lbl.pdf

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