Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPITOL | CARBAMAZEPINE | 200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/17/1986 | 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-71 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2020 | SUPPL-64 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/27/2020 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2014 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2014 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/19/2012 | SUPPL-53 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/31/2011 | SUPPL-52 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 07/09/2013 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2009 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 03/17/2008 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 08/01/2002 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/2002 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/13/1999 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/24/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/23/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/18/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/09/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/11/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
EPITOL
TABLET;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;ORAL | Prescription | No | AB | 075948 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 218221 | BIONPHARMA |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 074649 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 077272 | TORRENT PHARMS |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 207798 | UMEDICA |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 213284 | UNICHEM |
| EPITOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 070541 | TEVA |
| TEGRETOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 016608 | NOVARTIS |