FOCALIN - DEXMETHYLPHENIDATE HYDROCHLORIDE
Navigation: NDC > Supplier starting with: S > STAT RX USA LLC| Field | Value |
|---|---|
| NDC Code: | 16590-649 |
| Proprietary Name: | FOCALIN |
| Suffix: | XR |
| Non-Proprietary Name: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Dosage Form: | CAPSULE, EXTENDED RELEASE |
| Method: | ORAL |
| Original Marketing Date: | 31-05-2005 |
| Category Name: | NDA |
| Application Number: | NDA021802 |
| Labeler: | STAT RX USA LLC |
| Substance Name: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Active Numerator Strength: | 15 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
| DEA Schedule: | CII |