FdaApplication
ANDA 212244
Identifiers
- fda_app_no: ANDA212244
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2022-12-13 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL |
5 products