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-D 24 HOUR از شرکت BAYER HEALTHCARE LLC
New Drug Application (NDA): 020470
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITIN-D 24 HOUR | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/23/1996 | 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 |
|---|---|---|---|---|---|
| 07/31/2018 | SUPPL-47 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019670Orig1s034,020470Orig1s047ltr.pdf |
||
| 11/25/2015 | SUPPL-44 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf |
||
| 01/03/2014 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2010 | SUPPL-34 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf |
|
| 07/15/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20470s023ltr.pdf |
|
| 07/30/2004 | SUPPL-22 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf |
||
| 06/25/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20470slr019ltr.pdf |
|
| 12/09/2002 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-16 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm |
|
| 01/30/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml |
|
| 10/01/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-7 | 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 |
|
| 12/04/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20470-S005_Claritin.pdf |
|
| 05/04/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-3 | 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 |
|
| 10/06/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/26/1997 | 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 |
|---|---|---|---|---|---|
| 07/31/2018 | SUPPL-47 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf | |
| 11/25/2015 | SUPPL-44 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf | |
| 07/30/2004 | SUPPL-22 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf |
CLARITIN-D 24 HOUR
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 10MG;240MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLARITIN-D 24 HOUR | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 020470 | BAYER HEALTHCARE LLC |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075706 | P AND L |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075989 | PERRIGO PHARMA INTL |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076557 | SUN PHARM INDS LTD |
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