Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074649
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | 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 |
|---|---|---|---|---|---|---|---|
| 10/03/1996 | 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 |
|---|---|---|---|---|---|
| 02/28/2020 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-27 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/24/2012 | SUPPL-21 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 11/05/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/21/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/06/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/06/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CARBAMAZEPINE
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 |