| 0031-8765-04 |
0031-8765 |
HUMAN OTC DRUG |
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief |
Dextromethorphan Hydrobromide, Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190614 |
N/A |
ANDA |
ANDA207602 |
Haleon US Holdings LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BLISTER PACK in 1 CARTON (0031-8765-04) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 0031-8765-08 |
0031-8765 |
HUMAN OTC DRUG |
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief |
Dextromethorphan Hydrobromide, Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190614 |
N/A |
ANDA |
ANDA207602 |
Haleon US Holdings LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 0031-8765-16 |
0031-8765 |
HUMAN OTC DRUG |
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief |
Dextromethorphan Hydrobromide, Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190614 |
N/A |
ANDA |
ANDA207602 |
Haleon US Holdings LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 68196-812-45 |
68196-812 |
HUMAN OTC DRUG |
members mark mucus relief dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250403 |
N/A |
ANDA |
ANDA207602 |
Sam's West Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (68196-812-45) / 56 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 41250-812-55 |
41250-812 |
HUMAN OTC DRUG |
mucus dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20180808 |
N/A |
ANDA |
ANDA207602 |
Meijer Distribution Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (41250-812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 41250-812-66 |
41250-812 |
HUMAN OTC DRUG |
mucus dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20180808 |
N/A |
ANDA |
ANDA207602 |
Meijer Distribution Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (41250-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 41163-599-01 |
41163-599 |
HUMAN OTC DRUG |
equaline mucus dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20200218 |
N/A |
ANDA |
ANDA207602 |
United Natural Foods, Inc. dba UNFI |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (41163-599-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 11822-1812-0 |
11822-1812 |
HUMAN OTC DRUG |
mucus relief DM MAX |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20230313 |
N/A |
ANDA |
ANDA207602 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (11822-1812-0) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 11822-1812-1 |
11822-1812 |
HUMAN OTC DRUG |
mucus relief DM MAX |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20230316 |
N/A |
ANDA |
ANDA207602 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
2 BOTTLE in 1 CARTON (11822-1812-1) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 11822-1812-2 |
11822-1812 |
HUMAN OTC DRUG |
mucus relief DM MAX |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20230316 |
N/A |
ANDA |
ANDA207602 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
3 BOTTLE in 1 CARTON (11822-1812-2) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 50090-7891-0 |
50090-7891 |
HUMAN OTC DRUG |
RUGBY MUCUS RELIEF DM ER |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20260209 |
N/A |
ANDA |
ANDA207602 |
A-S Medication Solutions |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (50090-7891-0) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 42507-812-66 |
42507-812 |
HUMAN OTC DRUG |
mucus dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20260310 |
N/A |
ANDA |
ANDA207602 |
HyVee Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (42507-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (42507-812-14) |
| 70000-0722-1 |
70000-0722 |
HUMAN OTC DRUG |
Leader Mucus Relief DM |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250308 |
N/A |
ANDA |
ANDA207602 |
Cardinal Health 110, LLC. dba Leader |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (70000-0722-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 36800-592-30 |
36800-592 |
HUMAN OTC DRUG |
Topcare Mucus DM |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20220729 |
N/A |
ANDA |
ANDA207602 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (36800-592-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 36800-592-66 |
36800-592 |
HUMAN OTC DRUG |
Topcare Mucus DM |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20180906 |
N/A |
ANDA |
ANDA207602 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (36800-592-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 55910-746-01 |
55910-746 |
HUMAN OTC DRUG |
DG health mucus dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20230126 |
N/A |
ANDA |
ANDA207602 |
Dolgencorp Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (55910-746-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 55910-746-91 |
55910-746 |
HUMAN OTC DRUG |
DG health mucus dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20230201 |
N/A |
ANDA |
ANDA207602 |
Dolgencorp Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
6 BLISTER PACK in 1 CARTON (55910-746-91) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 37808-812-66 |
37808-812 |
HUMAN OTC DRUG |
mucus relief dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20180625 |
N/A |
ANDA |
ANDA207602 |
H E B |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (37808-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 0113-2219-01 |
0113-2219 |
HUMAN OTC DRUG |
Good Sense Mucus DM |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190710 |
N/A |
ANDA |
ANDA207602 |
L. Perrigo Company |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (0113-2219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 41250-436-01 |
41250-436 |
HUMAN OTC DRUG |
mucus relief dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20200602 |
N/A |
ANDA |
ANDA207602 |
Meijer Distribution Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (41250-436-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |