NUEDEXTA - dextromethorphan hydrobromide and quinidine sulfate
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Field |
Value |
NDC Code: |
64597-301 |
Proprietary Name: |
NUEDEXTA |
Suffix: |
|
Non-Proprietary Name: |
dextromethorphan hydrobromide and quinidine sulfate |
Dosage Form: |
CAPSULE, GELATIN COATED |
Method: |
ORAL |
Original Marketing Date: |
01-12-2010 |
Category Name: |
NDA |
Application Number: |
NDA021879 |
Labeler: |
AVANIR PHARMACEUTICALS, INC. |
Substance Name: |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
Active Numerator Strength: |
20; 10 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] |
DEA Schedule: |
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