OPANA - Oxymorphone Hydrochloride
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Field |
Value |
NDC Code: |
35356-389 |
Proprietary Name: |
OPANA |
Suffix: |
ER |
Non-Proprietary Name: |
Oxymorphone Hydrochloride |
Dosage Form: |
TABLET, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
10-11-2011 |
Category Name: |
NDA |
Application Number: |
NDA021610 |
Labeler: |
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
OXYMORPHONE HYDROCHLORIDE |
Active Numerator Strength: |
20 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |