PROMETHAZINE VC WITH CODEINE - PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE
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Field |
Value |
NDC Code: |
0472-1629 |
Proprietary Name: |
PROMETHAZINE VC WITH CODEINE |
Suffix: |
|
Non-Proprietary Name: |
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
Dosage Form: |
SYRUP |
Method: |
ORAL |
Original Marketing Date: |
19-12-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA088764 |
Labeler: |
ACTAVIS MID ATLANTIC LLC |
Substance Name: |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
Active Numerator Strength: |
10; 5; 6.25 |
Active Ingredient Unit: |
mg/5mL; mg/5mL; mg/5mL |
Pharm Classes: |
Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CV |