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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077031
Company: AUROBINDO

Other Important Information from FDA

Products on ANDA 077031

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077031

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
10/30/2023	SUPPL-43	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 077031

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	ABBVIE
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
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 PHARMS LTD
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	ABBVIE
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
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 PHARMS LTD
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	ABBVIE
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
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 PHARMS LTD
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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