FdaApplication
ANDA 212631
Identifiers
- fda_app_no: ANDA212631
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2019-07-19 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL |
3 products