FdaApplication
ANDA 215664
Identifiers
- fda_app_no: ANDA215664
Properties
| Property | Value |
|---|---|
| applicant_name | OSMOTICA PHARMACEUTICAL US LLC |
| application_type | ANDA |
| approval_date | 2024-10-22 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL |
3 products