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
CLARITIN از شرکت BAYER HEALTHCARE LLC
New Drug Application (NDA): 019658
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITIN | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter |
None |
Yes | Yes |
| CLARITIN HIVES RELIEF | LORATADINE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/12/1993 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 02/06/2019 | SUPPL-56 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019658Orig1s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019658Orig1s056ltr.pdf |
||
| 12/21/2018 | SUPPL-55 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2018/019658Orig1s055,021952Orig1s018Ltr.pdf |
||
| 10/03/2018 | SUPPL-54 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s054ltr.pdf |
||
| 07/05/2018 | SUPPL-53 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s053lbl.pdf |
||
| 05/30/2018 | SUPPL-52 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s052ltr.pdf |
||
| 05/30/2018 | SUPPL-51 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s051ltr.pdf |
||
| 01/12/2018 | SUPPL-50 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-48 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019658Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019658Orig1s048ltr.pdf |
||
| 12/14/2016 | SUPPL-46 | Labeling-Container/Carton Labels, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s046ltr.pdf |
||
| 08/09/2016 | SUPPL-45 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s045ltr.pdf |
||
| 12/18/2015 | SUPPL-44 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019658Orig1s044ltr.pdf |
||
| 09/14/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/2012 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2007 | SUPPL-26 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019658s026_rc.pdf |
||
| 06/25/2003 | SUPPL-21 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658slr021ltr.pdf |
|
| 11/19/2003 | SUPPL-20 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf |
|
| 12/10/2002 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-18 | Efficacy-Rx To OTC Switch |
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 |
|
| 07/23/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml |
|
| 01/27/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml |
|
| 01/27/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/14/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/01/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19658-S005_Claritin.pdf |
|
| 02/09/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1995 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/17/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/12/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/06/2019 | SUPPL-56 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019658Orig1s056lbl.pdf | |
| 12/21/2018 | SUPPL-55 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf | |
| 10/03/2018 | SUPPL-54 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s054lbl.pdf | |
| 07/05/2018 | SUPPL-53 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s053lbl.pdf | |
| 05/30/2018 | SUPPL-52 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s052lbl.pdf | |
| 05/30/2018 | SUPPL-51 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s051lbl.pdf | |
| 04/26/2017 | SUPPL-48 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019658Orig1s048lbl.pdf | |
| 12/14/2016 | SUPPL-46 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf | |
| 12/14/2016 | SUPPL-46 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf | |
| 08/09/2016 | SUPPL-45 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s045lbl.pdf | |
| 12/18/2015 | SUPPL-44 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf | |
| 12/20/2007 | SUPPL-26 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf |
CLARITIN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLARITIN | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019658 | BAYER HEALTHCARE LLC |
| CLARITIN HIVES RELIEF | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019658 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076471 | APOTEX INC |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 208314 | AUROBINDO PHARMA LTD |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 210722 | GRANULES |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 207569 | GUARDIAN DRUG |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076154 | MYLAN |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076301 | PERRIGO |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075209 | PLD ACQUISITIONS LLC |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076134 | SUN PHARM INDS LTD |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 214684 | UNIQUE PHARM |
CLARITIN HIVES RELIEF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLARITIN | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019658 | BAYER HEALTHCARE LLC |
| CLARITIN HIVES RELIEF | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019658 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076471 | APOTEX INC |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 208314 | AUROBINDO PHARMA LTD |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 210722 | GRANULES |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 207569 | GUARDIAN DRUG |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076154 | MYLAN |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076301 | PERRIGO |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075209 | PLD ACQUISITIONS LLC |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076134 | SUN PHARM INDS LTD |
| LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 214684 | UNIQUE PHARM |
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