Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077035
Company: FOSUN PHARMA
Company: FOSUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
10/28/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77035ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
12/18/2012 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/28/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
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10/19/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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10/19/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/01/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/11/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |