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 WOCKHARDT BIO AG
Abbreviated New Drug Application (ANDA): 075714
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 06/05/2002 | 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 |
|---|---|---|---|---|---|
| 01/26/2012 | SUPPL-7 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 12/15/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/14/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/11/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/09/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/05/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
CARBAMAZEPINE
SUSPENSION;ORAL; 100MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 075714 | WOCKHARDT BIO AG |
| TEGRETOL | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 018927 | NOVARTIS |
| TERIL | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 076729 | TARO |
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