| 27808-057-01 |
27808-057 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20211115 |
N/A |
ANDA |
ANDA091687 |
Cranbury Pharmaceuticals, LLC |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (27808-057-01) |
| 72162-2039-2 |
72162-2039 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20230606 |
N/A |
ANDA |
ANDA091687 |
Bryant Ranch Prepack |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (72162-2039-2) |
| 0713-0780-75 |
0713-0780 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20250919 |
N/A |
ANDA |
ANDA091687 |
Cosette Pharmaceuticals, Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (0713-0780-75) |
| 50090-6755-0 |
50090-6755 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20231017 |
N/A |
ANDA |
ANDA091687 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (50090-6755-0) |
| 50090-6755-1 |
50090-6755 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20240205 |
N/A |
ANDA |
ANDA091687 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
4 BOTTLE in 1 BOTTLE (50090-6755-1) / 118 mL in 1 BOTTLE |