Treats pain associated with true trigeminal neuralgia. NDA 20712, held by Takeda Pharms USA. Carbamazepine.
As of Nov 13, 2026, NDA 20712 (Carbatrol), held by Takeda Pharms USA, was first approved by FDA on Sep 30, 1997, with 26 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Epilepsy Carbatrol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Carbatrol200MG · capsule, extended release;oral | Carbamazepine | RxReference drug |
| Carbatrol300MG · capsule, extended release;oral | Carbamazepine | RxReference drug |
| Carbatrol100MG · capsule, extended release;oral | Carbamazepine | RxReference drug |
| Apr 11, 2023 | Supplement 38Labeling · Standard review | Approved | |
| Dec 1, 2021 | Supplement 37Labeling · Standard review | Approved | |
| Aug 26, 2018 | Supplement 36Labeling · Standard review | Approved | |
| Mar 22, 2013 | Supplement 32Labeling · Standard review | Approved | |
| Mar 22, 2013 | Supplement 35Labeling | Approved | |
| Aug 22, 2011 | Supplement 34REMS | Approved | |
| Jan 26, 2011 | Supplement 31Labeling · Standard review | Approved | |
| Apr 23, 2009 | Supplement 30Labeling | Approved | |
| Dec 11, 2007 | Supplement 29Labeling · Standard review | Approved | |
| Jun 30, 2006 | Supplement 25Labeling · Standard review | Approved | |
| Jan 24, 2006 | Supplement 24Labeling · Standard review | Approved | |
| Aug 7, 2002 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2002 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 30, 2001 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| May 17, 2001 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 8, 2000 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 8, 2000 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 14, 2000 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 19, 2000 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1999 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1999 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1997 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
