Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201450
Company: HETERO LABS LTD III

Products on ANDA 201450

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 201450

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2015	ORIG-1	Approval	Not Applicable			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-6	Labeling-Package Insert		Label is not available on this site.
09/21/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
09/13/2021	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201450

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