U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 Prescription AB No No
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription AB No No
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription AB 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
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-Medication Guide, Labeling-Package Insert

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.

CITALOPRAM HYDROBROMIDE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEXA CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 020822 ALLERGAN
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077289 AMNEAL PHARMS NY
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077046 APOTEX INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077031 AUROBINDO
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077044 CHARTWELL MOLECULAR
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077048 COSETTE
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077038 DR REDDYS LABS LTD
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077045 EPIC PHARMA
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077654 GLENMARK GENERICS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077534 INVAGEN PHARMS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077042 MYLAN
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 078216 TORRENT PHARMS

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEXA CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 020822 ALLERGAN
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077289 AMNEAL PHARMS NY
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077046 APOTEX INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077031 AUROBINDO
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077044 CHARTWELL MOLECULAR
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077048 COSETTE
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077038 DR REDDYS LABS LTD
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077045 EPIC PHARMA
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077654 GLENMARK GENERICS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077534 INVAGEN PHARMS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077042 MYLAN
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 078216 TORRENT PHARMS

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEXA CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription Yes AB 020822 ALLERGAN
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077289 AMNEAL PHARMS NY
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077046 APOTEX INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077031 AUROBINDO
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077044 CHARTWELL MOLECULAR
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077048 COSETTE
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077038 DR REDDYS LABS LTD
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077045 EPIC PHARMA
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077654 GLENMARK GENERICS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077534 INVAGEN PHARMS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077042 MYLAN
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 078216 TORRENT PHARMS
Back to Top