OXYCODONE AND ACETAMINOPHEN - oxycodone hydrochloride and acetaminophen
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Field |
Value |
NDC Code: |
49999-854 |
Proprietary Name: |
OXYCODONE AND ACETAMINOPHEN |
Suffix: |
|
Non-Proprietary Name: |
oxycodone hydrochloride and acetaminophen |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
01-02-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA040545 |
Labeler: |
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
Active Numerator Strength: |
325; 10 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |