Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075687
Company: TARO PHARM INDS
Company: TARO PHARM INDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, CHEWABLE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/24/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75687ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2020 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/24/2012 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2010 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/17/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
CARBAMAZEPINE
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 |