Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077812
Company: AUROBINDO PHARMA LTD
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
08/28/2006 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
01/04/2017 SUPPL-12 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.

07/15/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/29/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/29/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/25/2009 SUPPL-5 Labeling

Label is not available on this site.

01/13/2009 SUPPL-4 Labeling

Label is not available on this site.

07/02/2008 SUPPL-3 Labeling

Label is not available on this site.

10/25/2007 SUPPL-2 Labeling

Label is not available on this site.

07/02/2007 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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