FdaApplication
ANDA 204534
Identifiers
- fda_app_no: ANDA204534
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2015-12-04 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL |
3 products