Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020866
Company: VEROSCIENCE
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 |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.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 |