Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078986
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
11/25/2011 | 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 |
---|---|---|---|---|---|
08/08/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2022 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2022 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/18/2014 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
CARBATROL | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
CARBATROL | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
CARBATROL | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |