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
CUVPOSA از شرکت MERZ PHARMS
New Drug Application (NDA): 022571
Company: MERZ PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUVPOSA | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 07/28/2010 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2018 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022571s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022571Orig1s008ltr.pdf |
||
| 05/18/2016 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022571s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022571Orig1s006ltr.pdf |
||
| 02/08/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2015 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022571Orig1s004ltr.pdf |
||
| 05/21/2013 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022571s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022571Orig1s003ltr.pdf |
||
| 11/08/2012 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/23/2018 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022571s008lbl.pdf | |
| 05/18/2016 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022571s006lbl.pdf | |
| 11/06/2015 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf | |
| 05/21/2013 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022571s003lbl.pdf | |
| 07/28/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf |
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