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
CARBAMAZEPINE از شرکت TORRENT PHARMS
Abbreviated New Drug Application (ANDA): 075712
Company: TORRENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 07/05/2001 | 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 |
|---|---|---|---|---|---|
| 03/03/2021 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/03/2021 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2012 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-18 | Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2010 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2010 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/23/2010 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/11/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/17/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CARBAMAZEPINE
TABLET, CHEWABLE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 075687 | TARO PHARM INDS |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 075712 | TORRENT PHARMS |
| EPITOL | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 073524 | TEVA |
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