Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021891
Company: BAYER HEALTHCARE LLC
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 | No |
| CLARITIN | LORATADINE | 10MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 08/23/2006 | 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 |
|---|---|---|---|---|---|
| 12/27/2022 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021891Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021891Orig1s043ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/27/2022 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021891Orig1s043lbl.pdf | |
| 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 |