Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077043
Company: HIKMA

• Other Important Information from FDA

Products on ANDA 077043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077043ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/21/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/03/2021	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/04/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf
06/02/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/21/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/21/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/06/2009	SUPPL-6	Labeling		Label is not available on this site.
07/02/2008	SUPPL-5	Labeling		Label is not available on this site.
10/25/2007	SUPPL-4	Labeling		Label is not available on this site.
10/25/2007	SUPPL-3	Labeling		Label is not available on this site.
05/11/2005	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 077043

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf

Therapeutic Equivalents for ANDA 077043

CITALOPRAM HYDROBROMIDE

SOLUTION;ORAL; EQ 10MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	077812	AUROBINDO PHARMA
CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	077629	CHARTWELL MOLECULAR
CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	201450	HETERO LABS LTD III
CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	077043	HIKMA