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 COSETTE
Abbreviated New Drug Application (ANDA): 077048
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 11/16/2004 | 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 |
|---|---|---|---|---|---|
| 04/23/2013 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2012 | SUPPL-17 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/02/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/06/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/03/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/02/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/14/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/09/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
CITALOPRAM HYDROBROMIDE
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELEXA | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020822 | ALLERGAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077289 | AMNEAL PHARMS NY |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077046 | APOTEX INC |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077031 | AUROBINDO |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077044 | CHARTWELL MOLECULAR |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077048 | COSETTE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077038 | DR REDDYS LABS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077045 | EPIC PHARMA |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077654 | GLENMARK GENERICS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077534 | INVAGEN PHARMS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077042 | MYLAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078216 | TORRENT PHARMS |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELEXA | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020822 | ALLERGAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077289 | AMNEAL PHARMS NY |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077046 | APOTEX INC |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077031 | AUROBINDO |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077044 | CHARTWELL MOLECULAR |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077048 | COSETTE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077038 | DR REDDYS LABS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077045 | EPIC PHARMA |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077654 | GLENMARK GENERICS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077534 | INVAGEN PHARMS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077042 | MYLAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078216 | TORRENT PHARMS |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELEXA | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020822 | ALLERGAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077289 | AMNEAL PHARMS NY |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077046 | APOTEX INC |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077031 | AUROBINDO |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077044 | CHARTWELL MOLECULAR |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077048 | COSETTE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077038 | DR REDDYS LABS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077045 | EPIC PHARMA |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077654 | GLENMARK GENERICS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077534 | INVAGEN PHARMS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077042 | MYLAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 078216 | TORRENT PHARMS |
منبع : www.accessdata.fda.gov
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