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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077629
Company: LANNETT CO INC
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
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
09/21/2021 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/13/2021 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

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.

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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