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 TARO PHARM INDS
Abbreviated New Drug Application (ANDA): 075687
Company: TARO PHARM INDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;ORAL | Prescription |
AB |
No | Yes |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, CHEWABLE;ORAL | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 10/24/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75687ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2020 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-22 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2012 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/27/2010 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/17/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-1 | Manufacturing (CMC)-New Strength |
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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