Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020664
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOSTINEX CABERGOLINE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/23/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020664_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/30/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/26/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020664s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020664Orig1s013ltr.pdf
08/11/2011 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020664s012ltr.pdf
07/18/2011 SUPPL-11 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020664s011ltr.pdf
12/19/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020664s010ltr.pdf
12/12/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020664s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020664s008ltr.pdf
02/09/2007 SUPPL-7 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020664s007ltr.pdf
04/17/2000 SUPPL-4 Labeling

Label is not available on this site.

05/15/1998 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/15/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/15/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/26/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020664s013lbl.pdf
08/11/2011 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s012lbl.pdf
07/18/2011 SUPPL-11 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s011lbl.pdf
12/19/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s010lbl.pdf
02/09/2007 SUPPL-7 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s007lbl.pdf
12/12/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020664s008lbl.pdf

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