OPANA - OXYMORPHONE HYDROCHLORIDE
Navigation: NDC > Supplier starting with: S > STAT RX USA LLC| Field | Value |
|---|---|
| NDC Code: | 16590-609 |
| Proprietary Name: | OPANA |
| Suffix: | ER |
| Non-Proprietary Name: | OXYMORPHONE HYDROCHLORIDE |
| Dosage Form: | TABLET, FILM COATED, EXTENDED RELEASE |
| Method: | ORAL |
| Original Marketing Date: | 22-06-2006 |
| Category Name: | NDA |
| Application Number: | NDA021610 |
| Labeler: | STAT RX USA LLC |
| Substance Name: | OXYMORPHONE HYDROCHLORIDE |
| Active Numerator Strength: | 40 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule: | CII |