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Abbreviated New Drug Application (ANDA): 077031
Company: AUROBINDO
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
10/28/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77031ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2022 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/31/2022 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/31/2022 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/31/2022 SUPPL-31 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/30/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

04/25/2012 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

04/25/2012 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/06/2009 SUPPL-14 Labeling

Label is not available on this site.

01/14/2009 SUPPL-11 Labeling

Label is not available on this site.

07/02/2008 SUPPL-10 Labeling

Label is not available on this site.

10/25/2007 SUPPL-9 Labeling

Label is not available on this site.

10/25/2007 SUPPL-8 Labeling

Label is not available on this site.

06/28/2007 SUPPL-6 Labeling

Label is not available on this site.

04/09/2007 SUPPL-4 Labeling

Label is not available on this site.

04/07/2006 SUPPL-2 Labeling

Label is not available on this site.

02/06/2006 SUPPL-1 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
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