FdaApplication
NDA 021802
Identifiers
- fda_app_no: NDA021802
Properties
| Property | Value |
|---|---|
| applicant_name | SANDOZ INC |
| application_type | NDA |
| approval_date | 2005-05-26 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL |
8 products