Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077046
Company: APOTEX
Company: APOTEX
| 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 |
|---|---|---|---|---|---|---|---|
| 11/24/2004 | 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 |
|---|---|---|---|---|---|
| 06/03/2024 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/05/2022 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 10/05/2022 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 10/05/2022 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 10/05/2022 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/27/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/05/2014 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/25/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/17/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 06/17/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 12/17/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/28/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/26/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/29/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/24/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |