| 45802-433-21 |
45802-433 |
HUMAN OTC DRUG |
dextromethorphan polistirex extended release |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120910 |
N/A |
ANDA |
ANDA091135 |
Padagis Israel Pharmaceuticals Ltd |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE |
| 11822-0384-2 |
11822-0384 |
HUMAN OTC DRUG |
Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130718 |
N/A |
ANDA |
ANDA091135 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (11822-0384-2) / 148 mL in 1 BOTTLE |
| 11822-0384-1 |
11822-0384 |
HUMAN OTC DRUG |
Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120827 |
N/A |
ANDA |
ANDA091135 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (11822-0384-1) / 89 mL in 1 BOTTLE |
| 11822-0494-1 |
11822-0494 |
HUMAN OTC DRUG |
Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20150706 |
N/A |
ANDA |
ANDA091135 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (11822-0494-1) / 89 mL in 1 BOTTLE |
| 11822-0494-2 |
11822-0494 |
HUMAN OTC DRUG |
Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20220721 |
N/A |
ANDA |
ANDA091135 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (11822-0494-2) / 148 mL in 1 BOTTLE |
| 21130-012-21 |
21130-012 |
HUMAN OTC DRUG |
signature care 12 hour cough relief |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20150908 |
N/A |
ANDA |
ANDA091135 |
Safeway |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (21130-012-21) / 89 mL in 1 BOTTLE |
| 36800-494-21 |
36800-494 |
HUMAN OTC DRUG |
TopCare Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20150730 |
N/A |
ANDA |
ANDA091135 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (36800-494-21) / 89 mL in 1 BOTTLE |
| 36800-494-28 |
36800-494 |
HUMAN OTC DRUG |
TopCare Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20240808 |
N/A |
ANDA |
ANDA091135 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (36800-494-28) / 148 mL in 1 BOTTLE |
| 46122-141-21 |
46122-141 |
HUMAN OTC DRUG |
Good Neighbor Pharmacy Cough DM ER |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120830 |
N/A |
ANDA |
ANDA091135 |
Amerisource Bergen |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (46122-141-21) / 89 mL in 1 BOTTLE |
| 46122-141-25 |
46122-141 |
HUMAN OTC DRUG |
Good Neighbor Pharmacy Cough DM ER |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130802 |
N/A |
ANDA |
ANDA091135 |
Amerisource Bergen |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (46122-141-25) / 148 mL in 1 BOTTLE |
| 11822-0958-1 |
11822-0958 |
HUMAN OTC DRUG |
Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130724 |
N/A |
ANDA |
ANDA091135 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (11822-0958-1) / 89 mL in 1 BOTTLE |
| 36800-552-21 |
36800-552 |
HUMAN OTC DRUG |
Topcare Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120830 |
N/A |
ANDA |
ANDA091135 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (36800-552-21) / 89 mL in 1 BOTTLE |
| 70000-0195-1 |
70000-0195 |
HUMAN OTC DRUG |
leader childrens cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20161115 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0195-1) / 89 mL in 1 BOTTLE |
| 36800-552-28 |
36800-552 |
HUMAN OTC DRUG |
Topcare Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20130822 |
N/A |
ANDA |
ANDA091135 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (36800-552-28) / 148 mL in 1 BOTTLE |
| 70000-0187-1 |
70000-0187 |
HUMAN OTC DRUG |
Leader Cough DM |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20161205 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0187-1) / 89 mL in 1 BOTTLE |
| 0904-6312-56 |
0904-6312 |
HUMAN OTC DRUG |
cough dm |
dextromethorphan polistirex |
SUSPENSION |
ORAL |
20120906 |
N/A |
ANDA |
ANDA091135 |
Major Pharmaceuticals |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE |
| 21130-520-21 |
21130-520 |
HUMAN OTC DRUG |
Signature Care Cough Relief |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20210708 |
N/A |
ANDA |
ANDA091135 |
Safeway |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (21130-520-21) / 89 mL in 1 BOTTLE |
| 70000-0302-1 |
70000-0302 |
HUMAN OTC DRUG |
Leader Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20170606 |
N/A |
ANDA |
ANDA091135 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (70000-0302-1) / 89 mL in 1 BOTTLE |
| 41250-494-28 |
41250-494 |
HUMAN OTC DRUG |
Cough DM |
dextromethorphan polistirex |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20150326 |
N/A |
ANDA |
ANDA091135 |
Meijer Distribution Inc |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (41250-494-28) / 148 mL in 1 BOTTLE |
| 21130-890-21 |
21130-890 |
HUMAN OTC DRUG |
signature care childrens 12 hour cough relief |
Dextromethorphan polistirex |
SUSPENSION |
ORAL |
20220527 |
N/A |
ANDA |
ANDA091135 |
Safeway |
DEXTROMETHORPHAN HYDROBROMIDE |
30 mg/5mL |
1 BOTTLE in 1 CARTON (21130-890-21) / 89 mL in 1 BOTTLE |