Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077043
Company: HIKMA
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/13/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077043ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2021 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/03/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf
06/02/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/21/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/21/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/06/2009 SUPPL-6 Labeling

Label is not available on this site.

07/02/2008 SUPPL-5 Labeling

Label is not available on this site.

10/25/2007 SUPPL-4 Labeling

Label is not available on this site.

10/25/2007 SUPPL-3 Labeling

Label is not available on this site.

05/11/2005 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf

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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