Hydrocodone Bitartrate and Ibuprofen - Hydrocodone Bitartrate and Ibuprofen
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Field |
Value |
NDC Code: |
35356-804 |
Proprietary Name: |
Hydrocodone Bitartrate and Ibuprofen |
Suffix: |
|
Non-Proprietary Name: |
Hydrocodone Bitartrate and Ibuprofen |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
18-02-2010 |
Category Name: |
ANDA |
Application Number: |
ANDA076642 |
Labeler: |
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC CARE PRODUCST |
Substance Name: |
HYDROCODONE BITARTRATE; IBUPROFEN |
Active Numerator Strength: |
7.5; 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 |