Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020470
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN-D 24 HOUR LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None 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
08/23/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2018 SUPPL-47 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019670Orig1s034,020470Orig1s047ltr.pdf
11/25/2015 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf
01/03/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/26/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/13/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/25/2010 SUPPL-34 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf
07/15/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20470s023ltr.pdf
07/30/2004 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf
06/25/2003 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20470slr019ltr.pdf
12/09/2002 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/27/2002 SUPPL-16 Efficacy-Rx To OTC Switch Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm
01/30/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/2000 SUPPL-10 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml
10/01/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1998 SUPPL-7 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml
12/04/1998 SUPPL-5 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20470-S005_Claritin.pdf
05/04/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1998 SUPPL-3 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml
10/06/1997 SUPPL-2 Labeling

Label is not available on this site.

03/26/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2018 SUPPL-47 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf
11/25/2015 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf
07/30/2004 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf

CLARITIN-D 24 HOUR

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 10MG;240MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN-D 24 HOUR LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 020470 BAYER HEALTHCARE LLC
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075706 P AND L
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075989 PERRIGO PHARMA INTL
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076557 SUN PHARM INDS LTD

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