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 ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 071696
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 11/09/1987 | 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 |
|---|---|---|---|---|---|
| 01/11/2008 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/2000 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/20/2000 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/01/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/10/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/13/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/02/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/31/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-5 | Bioequivalence |
Label is not available on this site. |
||
| 09/28/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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