| 62135-302-24 |
62135-302 |
HUMAN PRESCRIPTION DRUG |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20241016 |
N/A |
ANDA |
ANDA213125 |
Chartwell RX, LLC |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
2 mg/5mL; 10 mg/5mL; 30 mg/5mL |
2 TRAY in 1 BOX (62135-302-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-302-05) |
| 62135-302-47 |
62135-302 |
HUMAN PRESCRIPTION DRUG |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20230123 |
N/A |
ANDA |
ANDA213125 |
Chartwell RX, LLC |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
2 mg/5mL; 10 mg/5mL; 30 mg/5mL |
473 mL in 1 BOTTLE (62135-302-47) |
| 62135-302-48 |
62135-302 |
HUMAN PRESCRIPTION DRUG |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20230123 |
N/A |
ANDA |
ANDA213125 |
Chartwell RX, LLC |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
2 mg/5mL; 10 mg/5mL; 30 mg/5mL |
118 mL in 1 BOTTLE (62135-302-48) |
| 68999-302-24 |
68999-302 |
HUMAN PRESCRIPTION DRUG |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
SYRUP |
ORAL |
20251030 |
N/A |
ANDA |
ANDA213125 |
Chartwell Governmental & Specialty RX, LLC |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
2 mg/5mL; 10 mg/5mL; 30 mg/5mL |
2 TRAY in 1 BOX (68999-302-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-302-05) |