Drugs@FDA: FDA-Approved Drugs
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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