| 70436-155-41 |
70436-155 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
SOLUTION |
ORAL |
20201005 |
N/A |
ANDA |
ANDA040649 |
Slate Run Pharmaceuticals, LLC |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
118 mL in 1 BOTTLE (70436-155-41) |
| 70436-155-42 |
70436-155 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
SOLUTION |
ORAL |
20201005 |
N/A |
ANDA |
ANDA040649 |
Slate Run Pharmaceuticals, LLC |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE (70436-155-42) |
| 0121-1070-04 |
0121-1070 |
HUMAN PRESCRIPTION DRUG |
Promethazine DM |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20250604 |
N/A |
ANDA |
ANDA040649 |
PAI Holdings, LLC dba PAI Pharma |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
118 mL in 1 BOTTLE (0121-1070-04) |
| 0121-1070-16 |
0121-1070 |
HUMAN PRESCRIPTION DRUG |
Promethazine DM |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
SOLUTION |
ORAL |
20250604 |
N/A |
ANDA |
ANDA040649 |
PAI Holdings, LLC dba PAI Pharma |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
473 mL in 1 BOTTLE (0121-1070-16) |
| 68071-3551-4 |
68071-3551 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
SOLUTION |
ORAL |
20231201 |
N/A |
ANDA |
ANDA040649 |
NuCare Pharmaceuticals,Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
118 mL in 1 BOTTLE (68071-3551-4) |
| 50090-6585-0 |
50090-6585 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral |
SOLUTION |
ORAL |
20230809 |
N/A |
ANDA |
ANDA040649 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
118 mL in 1 BOTTLE (50090-6585-0) |
| 71205-654-04 |
71205-654 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
SOLUTION |
ORAL |
20220426 |
N/A |
ANDA |
ANDA040649 |
Proficient Rx LP |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
118 mL in 1 BOTTLE (71205-654-04) |
| 17856-0155-1 |
17856-0155 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
SOLUTION |
ORAL |
20230913 |
N/A |
ANDA |
ANDA040649 |
ATLANTIC BIOLOGICALS CORP. |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE |
| 68788-8100-1 |
68788-8100 |
HUMAN PRESCRIPTION DRUG |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution |
SOLUTION |
ORAL |
20211008 |
N/A |
ANDA |
ANDA040649 |
Preferred Pharmaceuticals Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
15 mg/5mL; 6.25 mg/5mL |
118 mL in 1 BOTTLE (68788-8100-1) |