Opana - oxymorphone hydrochloride
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Field |
Value |
NDC Code: |
63481-817 |
Proprietary Name: |
Opana |
Suffix: |
ER |
Non-Proprietary Name: |
oxymorphone hydrochloride |
Dosage Form: |
TABLET, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
20-03-2012 |
Category Name: |
NDA |
Application Number: |
NDA201655 |
Labeler: |
ENDO PHARMACEUTICALS INC. |
Substance Name: |
OXYMORPHONE HYDROCHLORIDE |
Active Numerator Strength: |
30 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |