Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | 1 | EQUETRO | CARBAMAZEPINE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | 1 | EQUETRO | CARBAMAZEPINE |
| 003 | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | 1 | EQUETRO | CARBAMAZEPINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2004-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2007-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 8 | AP | 2010-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-11-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2016-09-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2016-09-23 | STANDARD |
| REMS; REMS | SUPPL | 13 | AP | 2012-01-27 | N/A |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-10-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 18 | Null | 7 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21710
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)