FdaApplication
ANDA 217248
Identifiers
- fda_app_no: ANDA217248
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2023-06-20 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL |
4 products