Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077036
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| 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/2004/77036ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/02/2009 | 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. |
||
| 06/27/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/24/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/29/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |