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
CYCLOSET از شرکت VEROSCIENCE
New Drug Application (NDA): 020866
Company: VEROSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOSET | BROMOCRIPTINE MESYLATE | EQ 0.8MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
05/05/2009 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866_cycloset_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2020 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020866Orig1s013ltr.pdf |
||
08/17/2020 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020866Orig1s012ltr.pdf |
||
02/02/2016 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020866Orig1s009ltr.pdf |
||
10/20/2015 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020866Orig1s008ltr.pdf |
||
02/06/2017 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020866Orig1s006,s007ltr.pdf |
||
02/06/2017 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020866Orig1s006,s007ltr.pdf |
||
03/14/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/12/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/24/2011 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020866s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/17/2020 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s012lbl.pdf | |
04/03/2020 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s013lbl.pdf | |
02/06/2017 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf | |
02/06/2017 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf | |
02/02/2016 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf | |
10/20/2015 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf | |
03/24/2011 | SUPPL-2 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf | |
03/24/2011 | SUPPL-2 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf | |
03/24/2011 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf |
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