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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077048
Company: COSETTE
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
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.

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