FdaApplication
ANDA 079108
Identifiers
- fda_app_no: ANDA079108
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2013-11-21 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL |
5 products