Drugs@FDA: FDA Approved Drug Products

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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 Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866_cycloset_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
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
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

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