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 24 HOUR از شرکت MERCK SHARP DOHME
New Drug Application (NDA): 021605
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARINEX D 24 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;240MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/03/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2019 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021605s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021165Orig1s022, 021300Orig1s019, 021312Orig1s020, 021563Orig1s008, 021313Orig1s012, 021605Orig1s017ltr.pdf |
||
| 02/28/2018 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021605Orig1s015ltr.pdf |
||
| 04/19/2018 | SUPPL-13 | 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 |
||
| 03/07/2014 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021605Orig1s012ltr.pdf |
||
| 12/30/2009 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021605s006ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/2019 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021605s017lbl.pdf | |
| 04/19/2018 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf | |
| 02/28/2018 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf | |
| 02/28/2018 | SUPPL-15 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf | |
| 03/07/2014 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf | |
| 12/30/2009 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf | |
| 03/03/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf |
نظرات کاربران