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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021046
Company: FOREST LABS

Medication Guide

Other Important Information from FDA

Products on NDA 021046

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CELEXA	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-046_Celexa.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2012	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021046s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf
03/27/2012	SUPPL-19	Labeling-Medication Guide	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822s042,021046s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021046Orig1s019.pdf
08/12/2011	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf
08/12/2011	SUPPL-16	Labeling-Medication Guide, Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf
01/30/2009	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf
09/18/2008	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,ltr.pdf
08/02/2007	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021046s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf
02/18/2005	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf
05/20/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf
04/08/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21046slr005,20822slr023ltr.pdf
11/19/2002	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20822slr019,21046slr003ltr.pdf
12/01/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021046

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2012	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021046s020lbl.pdf
03/27/2012	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf
08/12/2011	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
08/12/2011	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
08/12/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
01/30/2009	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf
09/18/2008	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf
08/02/2007	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021046s013lbl.pdf

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