Roxicodone - oxycodone hydrochloride
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Field |
Value |
NDC Code: |
66479-580 |
Proprietary Name: |
Roxicodone |
Suffix: |
|
Non-Proprietary Name: |
oxycodone hydrochloride |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
26-08-2009 |
End of Marketing: |
30-06-2014 |
Category Name: |
NDA |
Application Number: |
NDA021011 |
Labeler: |
XANODYNE PHARMACEUTICALS, INC. |
Substance Name: |
OXYCODONE HYDROCHLORIDE |
Active Numerator Strength: |
5 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |