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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077654
Company: GLENMARK GENERICS
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
02/27/2009 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
09/16/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/16/2022 SUPPL-2 Labeling-Patient Package Insert

Label is not available on this site.

09/16/2022 SUPPL-1 Labeling-Package Insert

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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