An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077038
Company: DR REDDYS LABS LTD

Other Important Information from FDA

Products on ANDA 077038

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 077038

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/2004/77038ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/10/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/26/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/26/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/06/2009	SUPPL-7	Labeling		Label is not available on this site.
01/22/2009	SUPPL-6	Labeling		Label is not available on this site.
08/13/2008	SUPPL-4	Labeling		Label is not available on this site.
10/19/2007	SUPPL-3	Labeling		Label is not available on this site.
04/27/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077038

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	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 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	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 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	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 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

Top