Oxycodone hydrochloride and Ibuprofen - Oxycodone hydrochloride and Ibuprofen
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Field |
Value |
NDC Code: |
35356-561 |
Proprietary Name: |
Oxycodone hydrochloride and Ibuprofen |
Suffix: |
|
Non-Proprietary Name: |
Oxycodone hydrochloride and Ibuprofen |
Dosage Form: |
TABLET, FILM COATED |
Method: |
ORAL |
Original Marketing Date: |
04-11-2008 |
Category Name: |
ANDA |
Application Number: |
ANDA078769 |
Labeler: |
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
IBUPROFEN; OXYCODONE HYDROCHLORIDE |
Active Numerator Strength: |
400; 5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule: |
CII |