Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020641
Company: BAYER HEALTHCARE LLC
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITIN | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | None | Yes | Yes |
| CLARITIN HIVES RELIEF | LORATADINE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/10/1996 | 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 |
|---|---|---|---|---|---|
| 02/28/2019 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020641Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020641Orig1s046ltr.pdf | |
| 05/14/2018 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020641Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020641Orig1s045ltr.pdf | |
| 08/09/2016 | SUPPL-42 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020641Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020641Orig1s042ltr.pdf | |
| 02/12/2016 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/2015 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s040ltr.pdf | |
| 12/10/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/2015 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s038ltr.pdf | |
| 10/21/2015 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s037ltr.pdf | |
| 04/16/2015 | SUPPL-36 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s036ltr.pdf | |
| 05/15/2014 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2013 | SUPPL-32 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020641Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020641Orig1s032ltr.pdf | |
| 11/20/2012 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2008 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s025ltr.pdf |
| 07/25/2008 | SUPPL-24 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s024ltr.pdf |
| 06/14/2005 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020641s018ltr.pdf |
| 10/27/2004 | SUPPL-17 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s017ltr.pdf |
| 07/15/2004 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s016ltr.pdf |
| 12/09/2002 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/19/2003 | SUPPL-11 | 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 |
| 07/23/2002 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-9 | 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 |
| 12/04/2000 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641S007_Loratadine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641s007_LoratadineClaritin.cfm | |
| 01/07/1999 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-3 | 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 |
| 03/30/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-1 | 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2019 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020641Orig1s046lbl.pdf | |
| 05/14/2018 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020641Orig1s045lbl.pdf | |
| 08/09/2016 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020641Orig1s042lbl.pdf | |
| 12/30/2015 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf | |
| 11/12/2015 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s038lbl.pdf | |
| 10/21/2015 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641s037lbl.pdf | |
| 04/16/2015 | SUPPL-36 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf |
| 02/28/2013 | SUPPL-32 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020641Orig1s032lbl.pdf |
| 12/04/2000 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf |
CLARITIN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SYRUP;ORAL; 1MG/ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLARITIN | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | Yes | 020641 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 208931 | AUROBINDO PHARMA LTD |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 210409 | HETERO LABS LTD III |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 077421 | LANNETT CO INC |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 075728 | PERRIGO |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 076805 | TARO |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 201865 | TARO |
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 075815 | WOCKHARDT BIO AG |
CLARITIN HIVES RELIEF
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.