Hydrocodone Bitartrate and Acetaminophen - Hydrocodone Bitartrate and Acetaminophen
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Field |
Value |
NDC Code: |
45865-412 |
Proprietary Name: |
Hydrocodone Bitartrate and Acetaminophen |
Suffix: |
|
Non-Proprietary Name: |
Hydrocodone Bitartrate and Acetaminophen |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
18-02-2010 |
Category Name: |
ANDA |
Application Number: |
ANDA040754 |
Labeler: |
MEDSOURCE PHARMACEUTICALS |
Substance Name: |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Active Numerator Strength: |
650; 7.5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule: |
CIII |