Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020822
Company: ABBVIE

• Medication Guide

Products on NDA 20822

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CELEXA	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
CELEXA	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
CELEXA	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes
CELEXA	CITALOPRAM HYDROBROMIDE	EQ 60MG BASE	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 020822

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020822s055lbl.pdf
08/18/2023	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020822s054lbl.pdf
02/04/2022	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020822s041lbl.pdf
09/20/2021	SUPPL-52	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020822s052lbl.pdf
09/20/2021	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020822s052lbl.pdf
01/11/2019	SUPPL-51	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020822s051lbl.pdf
01/04/2017	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf
07/08/2014	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf
04/16/2014	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822s045lbl.pdf
12/03/2012	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf
03/27/2012	SUPPL-42	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf
08/12/2011	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
08/12/2011	SUPPL-38	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
01/30/2009	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf
09/18/2008	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf
08/02/2007	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf
02/18/2005	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf
07/17/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20822lbl.pdf