Reprexain - hydrocodone bitartrate, ibuprofen
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Supplier starting with: H > HAWTHORN PHARMACEUTICALS, INC.
Field |
Value |
NDC Code: |
63717-900 |
Proprietary Name: |
Reprexain |
Suffix: |
|
Non-Proprietary Name: |
hydrocodone bitartrate, ibuprofen |
Dosage Form: |
TABLET, FILM COATED |
Method: |
ORAL |
Original Marketing Date: |
16-12-2008 |
Category Name: |
ANDA |
Application Number: |
ANDA076642 |
Labeler: |
HAWTHORN PHARMACEUTICALS, INC. |
Substance Name: |
HYDROCODONE BITARTRATE; IBUPROFEN |
Active Numerator Strength: |
2.5; 200 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule: |
CIII |