| 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 |
| 36800-219-01 |
36800-219 |
HUMAN OTC DRUG |
Topcare Mucus DM |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190710 |
N/A |
ANDA |
ANDA207602 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (36800-219-01) / 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 |
| 0536-1446-34 |
0536-1446 |
HUMAN OTC DRUG |
Rugby Mucus Relief DM ER |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250402 |
N/A |
ANDA |
ANDA207602 |
Rugby Laboratories |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (0536-1446-34) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 0363-6812-30 |
0363-6812 |
HUMAN OTC DRUG |
mucus relief dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190107 |
N/A |
ANDA |
ANDA207602 |
Walgreen Company |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (0363-6812-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 0363-6812-55 |
0363-6812 |
HUMAN OTC DRUG |
mucus relief dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20181221 |
N/A |
ANDA |
ANDA207602 |
Walgreen Company |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (0363-6812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 69842-963-01 |
69842-963 |
HUMAN OTC DRUG |
mucus dm extended release |
guaifenesin, dextromethorphan hydrobromide |
TABLET, EXTENDED RELEASE |
ORAL |
20190913 |
N/A |
ANDA |
ANDA207602 |
CVS Pharmacy |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (69842-963-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 36800-219-49 |
36800-219 |
HUMAN OTC DRUG |
Topcare Mucus DM |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20220413 |
N/A |
ANDA |
ANDA207602 |
Topco Associates LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (36800-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 79903-065-01 |
79903-065 |
HUMAN OTC DRUG |
equate mucus relief dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20210623 |
N/A |
ANDA |
ANDA207602 |
Wal-Mart Stores Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (79903-065-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 79903-065-49 |
79903-065 |
HUMAN OTC DRUG |
equate mucus relief dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20210629 |
N/A |
ANDA |
ANDA207602 |
Wal-Mart Stores Inc |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (79903-065-49) / 40 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 |
| 0113-2219-49 |
0113-2219 |
HUMAN OTC DRUG |
Good Sense Mucus DM |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20230619 |
N/A |
ANDA |
ANDA207602 |
L. Perrigo Company |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (0113-2219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 46122-817-61 |
46122-817 |
HUMAN OTC DRUG |
GOOD NEIGHBOR PHARMACY MUCUS DM |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250912 |
N/A |
ANDA |
ANDA207602 |
Amerisource Bergen |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (46122-817-61) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 41163-781-66 |
41163-781 |
HUMAN OTC DRUG |
Equaline Mucus DM |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20200224 |
N/A |
ANDA |
ANDA207602 |
United Natural Foods, Inc. dba UNFI |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (41163-781-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 72288-812-55 |
72288-812 |
HUMAN OTC DRUG |
basic care mucus dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20210713 |
N/A |
ANDA |
ANDA207602 |
Amazon.com Services LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (72288-812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 72288-812-66 |
72288-812 |
HUMAN OTC DRUG |
basic care mucus dm |
dextromethorphan HBr, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20210709 |
N/A |
ANDA |
ANDA207602 |
Amazon.com Services LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (72288-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 11673-716-01 |
11673-716 |
HUMAN OTC DRUG |
up and up mucus relief dm |
dextromethorphan hydrobromide, guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20190715 |
N/A |
ANDA |
ANDA207602 |
Target Corporation |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE in 1 CARTON (11673-716-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE |