| NDC Code: |
16590-897 |
| Proprietary Name: |
EMBEDA |
| Suffix: |
|
| Non-Proprietary Name: |
MORPHINE SUFATE |
| Dosage Form: |
CAPSULE, EXTENDED RELEASE |
| Method: |
ORAL |
| Original Marketing Date: |
13-08-2009 |
| Category Name: |
NDA |
| Application Number: |
NDA022321 |
| Labeler: |
STAT RX USA LLC |
| Substance Name: |
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE |
| Active Numerator Strength: |
20; .8 |
| Active Ingredient Unit: |
mg/1; mg/1 |
| Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
| DEA Schedule: |
CII |
