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 APOTEX INC
Abbreviated New Drug Application (ANDA): 075948
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/27/2002 | 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 |
|---|---|---|---|---|---|
| 04/20/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2011 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |
||
| 11/25/2009 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/15/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CARBAMAZEPINE
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 075948 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 074649 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 077272 | TORRENT PHARMS |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 207798 | UMEDICA LABS PVT LTD |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 214328 | VGYAAN |
| EPITOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 070541 | TEVA |
| TEGRETOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 016608 | NOVARTIS |
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