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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020664
Company: PFIZER

Products on NDA 020664

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DOSTINEX	CABERGOLINE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020664

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
12/13/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020664s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020664Orig1s017ltr.pdf
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.

Labels for NDA 020664

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020664s017lbl.pdf
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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