Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207798
Company: UMEDICA
Company: UMEDICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET;ORAL | Prescription | BX | No | No |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | BX | 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 |
---|---|---|---|---|---|---|---|
04/15/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
CARBAMAZEPINE
There are no Therapeutic Equivalents.