Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021605
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARINEX D 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG TABLET, EXTENDED RELEASE;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
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
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

CLARINEX D 24 HOUR

TABLET, EXTENDED RELEASE;ORAL; 5MG;240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX D 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021605 MERCK SHARP DOHME
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078366 DR REDDYS LABS LTD

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