Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPITOL | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 07/29/1992 | 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 |
|---|---|---|---|---|---|
| 11/21/2022 | SUPPL-53 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/27/2020 | SUPPL-48 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/27/2020 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2014 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2012 | SUPPL-37 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/31/2011 | SUPPL-36 | REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2011 | SUPPL-35 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/17/2010 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/26/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 04/23/2002 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/13/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/04/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
EPITOL
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 |