FdaApplication
ANDA 213369
Identifiers
- fda_app_no: ANDA213369
Properties
| Property | Value |
|---|---|
| applicant_name | APOTEX INC |
| application_type | ANDA |
| approval_date | 2023-07-13 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET, EXTENDED RELEASE;ORAL |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET, EXTENDED RELEASE;ORAL |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET, EXTENDED RELEASE;ORAL |
3 products