Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078216
Company: TORRENT PHARMS
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
03/27/2007 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
12/10/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

03/28/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/26/2012 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

06/26/2012 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

06/22/2009 SUPPL-10 Labeling

Label is not available on this site.

01/20/2011 SUPPL-9 Labeling

Label is not available on this site.

01/23/2009 SUPPL-7 Labeling

Label is not available on this site.

08/13/2008 SUPPL-3 Labeling

Label is not available on this site.

10/25/2007 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 077048 ACP NIMBLE
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 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 077232 HERITAGE PHARMA
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 205407 JUBILANT GENERICS
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 077032 SUN PHARM INDS INC
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 077048 ACP NIMBLE
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 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 077232 HERITAGE PHARMA
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 205407 JUBILANT GENERICS
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 077032 SUN PHARM INDS INC
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 077048 ACP NIMBLE
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 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 077232 HERITAGE PHARMA
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 205407 JUBILANT GENERICS
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 077032 SUN PHARM INDS INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 078216 TORRENT PHARMS

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