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
Abbreviated New Drug Application (ANDA): 078115
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/31/2009 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078115s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2020 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/24/2012 | SUPPL-5 | Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2010 | SUPPL-2 | Labeling |
Label is not available on this site. |
CARBAMAZEPINE
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
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