اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CITALOPRAM HYDROBROMIDE از شرکت AUROBINDO PHARMA LTD
Abbreviated New Drug Application (ANDA): 077812
Company: AUROBINDO PHARMA LTD
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 08/28/2006 | 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 |
|---|---|---|---|---|---|
| 01/04/2017 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/13/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/02/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/25/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/02/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
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 |
منبع : www.accessdata.fda.gov
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