Roxicet - Oxycodone and Acetaminophen
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Supplier starting with: R > ROXANE LABORATORIES, INC.
Field |
Value |
NDC Code: |
0054-4784 |
Proprietary Name: |
Roxicet |
Suffix: |
|
Non-Proprietary Name: |
Oxycodone and Acetaminophen |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
12-01-1989 |
Category Name: |
ANDA |
Application Number: |
ANDA089775 |
Labeler: |
ROXANE LABORATORIES, INC. |
Substance Name: |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
Active Numerator Strength: |
500; 5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |