| NDC Code: |
27808-065 |
| Proprietary Name: |
Promethazine Hydrochloride and Codeine Phosphate |
| Suffix: |
|
| Non-Proprietary Name: |
Promethazine Hydrochloride and Codeine Phosphate |
| Dosage Form: |
SYRUP |
| Method: |
ORAL |
| Original Marketing Date: |
15-05-2013 |
| Category Name: |
ANDA |
| Application Number: |
ANDA200386 |
| Labeler: |
TRIS PHARMA INC |
| Substance Name: |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
| Active Numerator Strength: |
10; 6.25 |
| Active Ingredient Unit: |
mg/5mL; mg/5mL |
| Pharm Classes: |
Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule: |
CV |
