Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077048
Company: COSETTE PHARMS NC

• Other Important Information from FDA

Products on ANDA 077048

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2024	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2024	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/23/2013	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/19/2012	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/26/2012	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/02/2009	SUPPL-14	Labeling		Label is not available on this site.
04/02/2009	SUPPL-13	Labeling		Label is not available on this site.
01/06/2009	SUPPL-12	Labeling		Label is not available on this site.
04/03/2008	SUPPL-9	Labeling		Label is not available on this site.
07/02/2007	SUPPL-8	Labeling		Label is not available on this site.
12/14/2005	SUPPL-3	Labeling		Label is not available on this site.
06/09/2005	SUPPL-2	Labeling		Label is not available on this site.