FdaApplication
ANDA 078986
Identifiers
- fda_app_no: ANDA078986
Properties
| Property | Value |
|---|---|
| applicant_name | APOTEX INC |
| application_type | ANDA |
| approval_date | 2011-11-25 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL |
3 products