Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218221
Company: BIONPHARMA
Company: BIONPHARMA
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 |
---|---|---|---|---|---|---|---|
02/16/2024 | ORIG-1 | Approval | STANDARD |
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 | 213284 | UNICHEM |
EPITOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 070541 | TEVA |
TEGRETOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 016608 | NOVARTIS |