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Abbreviated New Drug Application (ANDA): 077629
Company: CHARTWELL MOLECULAR

• Other Important Information from FDA

Products on ANDA 077629

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077629

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2006	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
08/18/2023	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2021	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2021	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2021	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/01/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/01/2013	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/21/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/11/2009	SUPPL-4	Labeling		Label is not available on this site.
07/02/2008	SUPPL-3	Labeling		Label is not available on this site.
07/02/2007	SUPPL-2	Labeling		Label is not available on this site.
07/12/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077629

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