Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020704
Company: BAYER HEALTHCARE LLC
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITIN HIVES RELIEF REDITAB | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | None | Yes | Yes |
| CLARITIN REDITABS | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 12/23/1996 | 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 |
|---|---|---|---|---|---|
| 05/25/2023 | SUPPL-41 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020704Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020704Orig1s041ltr.pdf | |
| 01/11/2021 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020704Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020704Orig1s037ltr.pdf | |
| 05/07/2019 | SUPPL-35 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020704Orig1s035ltr.pdf | |
| 02/28/2019 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020704Orig1s034, 021993Orig1s017ltr.pdf | |
| 07/23/2018 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021993Orig1s016,020704Orig1s033ltr.pdf | |
| 05/16/2017 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020704Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020704Orig1s032ltr.pdf | |
| 11/04/2016 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020704Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020704Orig1s029ltr.pdf | |
| 11/25/2015 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf | |
| 07/22/2014 | SUPPL-27 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf | |
| 01/29/2009 | SUPPL-21 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020704s021ltr.pdf |
| 10/21/2008 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020704s020ltr.pdf |
| 01/19/2006 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020704s014ltr.pdf |
| 11/19/2003 | SUPPL-9 | Efficacy-Rx To OTC Switch |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf |
| 11/27/2002 | SUPPL-8 | Efficacy-Rx To OTC Switch |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm |
| 09/18/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-4 | 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 |
| 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 |
| 09/19/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/25/2023 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020704Orig1s041lbl.pdf | |
| 01/11/2021 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020704Orig1s037lbl.pdf | |
| 05/07/2019 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s035lbl.pdf | |
| 02/28/2019 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf | |
| 07/23/2018 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf | |
| 05/16/2017 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020704Orig1s032lbl.pdf | |
| 11/04/2016 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020704Orig1s029lbl.pdf | |
| 11/25/2015 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf | |
| 07/22/2014 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf |
CLARITIN HIVES RELIEF REDITAB
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALAVERT | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 021375 | FDN CONSUMER |
| CLARITIN HIVES RELIEF REDITAB | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 020704 | BAYER HEALTHCARE LLC |
| CLARITIN REDITABS | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 020704 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 208477 | AUROBINDO PHARMA LTD |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 076011 | PERRIGO PHARMA INTL |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 214280 | RUBICON |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 213294 | TENSHI |
| LORATADINE REDIDOSE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 077153 | SUN PHARM INDS LTD |
CLARITIN REDITABS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALAVERT | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 021375 | FDN CONSUMER |
| CLARITIN HIVES RELIEF REDITAB | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 020704 | BAYER HEALTHCARE LLC |
| CLARITIN REDITABS | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 020704 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 208477 | AUROBINDO PHARMA LTD |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 076011 | PERRIGO PHARMA INTL |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 214280 | RUBICON |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 213294 | TENSHI |
| LORATADINE REDIDOSE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 077153 | SUN PHARM INDS LTD |