Drugs@FDA: FDA-Approved Drugs

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

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 LTD
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
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION;ORAL Prescription No AA 077629 LANNETT CO INC

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