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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021483
Company: PFIZER INC

Other Important Information from FDA

Products on NDA 021483

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEODON	ZIPRASIDONE HYDROCHLORIDE	EQ 10MG BASE/ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021483

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021483s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021483s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020825Orig1s056,021483Orig1s015,020919Orig1s044ltr.pdf
08/20/2015	SUPPL-14	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf
12/10/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf
05/21/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/13/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf
03/01/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf
07/03/2013	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf
12/01/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf
08/07/2009	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021483s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021483s003ltr.pdf

Labels for NDA 021483

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf
02/23/2017	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf
08/20/2015	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf
08/20/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf
12/10/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf
08/13/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf
07/03/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf
03/01/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf
12/01/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf
08/07/2009	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021483s003lbl.pdf

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