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 HIKMA
Abbreviated New Drug Application (ANDA): 077043
Company: HIKMA
| 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 | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/13/2004 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077043ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf |
||
| 06/02/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2009 | 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. |
||
| 10/25/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/11/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf |
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 |
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