Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021891
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S CLARITIN LORATADINE 5MG TABLET, CHEWABLE;ORAL Over-the-counter None Yes Yes
CLARITIN LORATADINE 10MG TABLET, CHEWABLE;ORAL Over-the-counter None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/23/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021891lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021891s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021891s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2018 SUPPL-29 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021891s029ltr.pdf
01/03/2019 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021891Orig1s028ltr.pdf
07/20/2018 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s027Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021891Orig1s027Ltr.pdf
02/15/2018 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021891Orig1s026ltr.pdf
05/22/2017 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021891Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021891Orig1s023ltr.pdf
04/05/2016 SUPPL-21 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021891Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021891Orig1s021ltr.pdf
12/23/2015 SUPPL-20 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021891Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021891Orig1s020ltr.pdf
09/24/2015 SUPPL-19 Labeling-Container/Carton Labels

Label is not available on this site.

07/25/2014 SUPPL-18 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021891Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021891Orig1s018ltr.pdf
09/10/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/04/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/03/2010 SUPPL-8 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021891s008ltr.pdf
10/08/2008 SUPPL-5 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021891s005ltr.pdf
10/21/2008 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021891s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/03/2019 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s028lbl.pdf
11/21/2018 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s029lbl.pdf
07/20/2018 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s027Lbl.pdf
02/15/2018 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s026lbl.pdf
05/22/2017 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021891Orig1s023lbl.pdf
04/05/2016 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021891Orig1s021lbl.pdf
12/23/2015 SUPPL-20 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021891Orig1s020lbl.pdf
07/25/2014 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021891Orig1s018lbl.pdf
08/23/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021891lbl.pdf

CHILDREN'S CLARITIN

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

TABLET, CHEWABLE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CLARITIN LORATADINE 5MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021891 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 210088 SUN PHARM

CLARITIN

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

TABLET, CHEWABLE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 10MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021891 BAYER HEALTHCARE LLC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English