Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077289
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| 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 |
|---|---|---|---|---|---|---|---|
| 11/30/2006 | 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 |
|---|---|---|---|---|---|
| 09/19/2024 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-31 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/03/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/03/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/03/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/25/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/13/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/03/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 03/20/2008 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |