| NDC Code: |
65162-680 |
| Proprietary Name: |
Promethazine Hydrochloride and Dextomethorphan Hydrobromide |
| Suffix: |
|
| Non-Proprietary Name: |
Promethazine Hydrochloride and Dextomethorphan Hydrobromide |
| Dosage Form: |
SOLUTION |
| Method: |
ORAL |
| Original Marketing Date: |
31-03-2010 |
| Category Name: |
ANDA |
| Application Number: |
ANDA090575 |
| Labeler: |
AMNEAL PHARMACEUTICALS |
| Substance Name: |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
| Active Numerator Strength: |
15; 6.25 |
| Active Ingredient Unit: |
mg/5mL; mg/5mL |
| Pharm Classes: |
Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] |
| DEA Schedule: |
|
