| 0116-4024-16 |
0116-4024 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20250407 |
N/A |
ANDA |
ANDA088864 |
Xttrium Laboratories, Inc |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (0116-4024-16) |
| 17856-0604-4 |
17856-0604 |
HUMAN PRESCRIPTION DRUG |
Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
SYRUP |
ORAL |
20240605 |
N/A |
ANDA |
ANDA088864 |
ATLANTIC BIOLOGICALS CORP. |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
72 CUP in 1 BOX (17856-0604-4) / 5 mL in 1 CUP (17856-0604-5) |
| 50090-7658-0 |
50090-7658 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20250922 |
N/A |
ANDA |
ANDA088864 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (50090-7658-0) |
| 50090-7658-1 |
50090-7658 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20250922 |
N/A |
ANDA |
ANDA088864 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (50090-7658-1) |
| 50090-6467-0 |
50090-6467 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
promethazine hydrochloride and dextromethorphan hydrobromide |
SYRUP |
ORAL |
20230508 |
N/A |
ANDA |
ANDA088864 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (50090-6467-0) |
| 50090-6467-1 |
50090-6467 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
promethazine hydrochloride and dextromethorphan hydrobromide |
SYRUP |
ORAL |
20230508 |
N/A |
ANDA |
ANDA088864 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE, PLASTIC (50090-6467-1) |