ENDOCET - Oxycodone and Acetaminophen
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Field |
Value |
NDC Code: |
49999-830 |
Proprietary Name: |
ENDOCET |
Suffix: |
|
Non-Proprietary Name: |
Oxycodone and Acetaminophen |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
02-03-2012 |
Category Name: |
ANDA |
Application Number: |
ANDA040341 |
Labeler: |
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUTCS LLC |
Substance Name: |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
Active Numerator Strength: |
500; 7.5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |