CHILDREN’S CLARITIN از شرکت BAYER HEALTHCARE LLC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CHILDREN’S CLARITIN از شرکت BAYER HEALTHCARE LLC

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
04/02/2021 SUPPL-38 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021891Orig1s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021891Orig1s038ltr.pdf

01/07/2021 SUPPL-36 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021891Orig1s036lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021891Orig1s036ltr.pdf

08/07/2020 SUPPL-34 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021891Orig1s034lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021891Orig1s034ltr.pdf

10/03/2019 SUPPL-33 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s033lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021891Orig1s033ltr.pdf

11/07/2019 SUPPL-32 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021891Orig1s032ltr.pdf

06/17/2019 SUPPL-31 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s031lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021891Orig1s031ltr.pdf

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/2018/021891Orig1s029ltr.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
04/02/2021 SUPPL-38

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021891Orig1s038lbl.pdf
01/07/2021 SUPPL-36

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021891Orig1s036lbl.pdf
08/07/2020 SUPPL-34

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021891Orig1s034lbl.pdf
11/07/2019 SUPPL-32

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s032lbl.pdf
10/03/2019 SUPPL-33

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s033lbl.pdf
06/17/2019 SUPPL-31

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021891Orig1s031lbl.pdf
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 210033 PERRIGO PHARMA INTL
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
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