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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021605
Company: ORGANON

Products on NDA 021605

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARINEX D 24 HOUR	DESLORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021605

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021605ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021605s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021605s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021165Orig1s022, 021300Orig1s019, 021312Orig1s020, 021563Orig1s008, 021313Orig1s012, 021605Orig1s017ltr.pdf
02/28/2018	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021605Orig1s015ltr.pdf
04/19/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s010,021605Orig1s013ltr.pdf
03/07/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021605Orig1s012ltr.pdf
12/30/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021605s006ltr.pdf

Labels for NDA 021605

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021605s017lbl.pdf
04/19/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf
02/28/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf
02/28/2018	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf
03/07/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf
12/30/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf
03/03/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf

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