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
CLARINEX-D 12 HOUR از شرکت ORGANON
New Drug Application (NDA): 021313
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARINEX-D 12 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | 2.5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 02/01/2006 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021313s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2019 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021313s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021165Orig1s022, 021300Orig1s019, 021312Orig1s020, 021563Orig1s008, 021313Orig1s012, 021605Orig1s017ltr.pdf |
||
| 04/19/2018 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s010,021605Orig1s013ltr.pdf |
||
| 02/06/2018 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s009ltr.pdf |
||
| 10/16/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/2014 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021313s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021313Orig1s005ltr.pdf |
||
| 12/30/2009 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021313s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021313s002ltr.pdf |
||
| 07/19/2007 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021313s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021313s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/2019 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021313s012lbl.pdf | |
| 04/19/2018 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf | |
| 02/06/2018 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s009lbl.pdf | |
| 03/07/2014 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021313s005lbl.pdf | |
| 12/30/2009 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021313s002lbl.pdf | |
| 07/19/2007 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021313s001lbl.pdf | |
| 02/01/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021313s000lbl.pdf |
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