| 65162-039-03 |
65162-039 |
HUMAN OTC DRUG |
Guaifenesin and Dextromethorphan HBr |
Guaifenesin and Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20181101 |
N/A |
ANDA |
ANDA209692 |
Amneal Pharmaceuticals LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 65162-039-06 |
65162-039 |
HUMAN OTC DRUG |
Guaifenesin and Dextromethorphan HBr |
Guaifenesin and Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20181101 |
N/A |
ANDA |
ANDA209692 |
Amneal Pharmaceuticals LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 65162-039-17 |
65162-039 |
HUMAN OTC DRUG |
Guaifenesin and Dextromethorphan HBr |
Guaifenesin and Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20181101 |
N/A |
ANDA |
ANDA209692 |
Amneal Pharmaceuticals LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 70677-1050-1 |
70677-1050 |
HUMAN OTC DRUG |
Mucus Relief DM |
Guaifenesin, Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20230331 |
N/A |
ANDA |
ANDA209692 |
Strategic Sourcing Services LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
20 BLISTER PACK in 1 CARTON (70677-1050-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 83324-137-14 |
83324-137 |
HUMAN OTC DRUG |
Mucus Relief DM |
Guaifenesin Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20240731 |
N/A |
ANDA |
ANDA209692 |
QUALITY CHOICE (Chain Drug Marketing Association) |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
14 BLISTER PACK in 1 CARTON (83324-137-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 11822-7340-4 |
11822-7340 |
HUMAN OTC DRUG |
Mucus Relief DM Maximum Strength |
Guaifenesin, Dextromethorphan HBr |
TABLET |
ORAL |
20190531 |
20261231 |
ANDA |
ANDA209692 |
Rite Aid Corporation |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
42 BLISTER PACK in 1 CARTON (11822-7340-4) / 1 TABLET in 1 BLISTER PACK |
| 0536-1161-34 |
0536-1161 |
HUMAN OTC DRUG |
Mucus Relief DM Extended Release Caplets |
Guaifenesin, Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20181213 |
N/A |
ANDA |
ANDA209692 |
Rugby Laboratories, Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 0536-1161-37 |
0536-1161 |
HUMAN OTC DRUG |
Mucus Relief DM Extended Release Caplets |
Guaifenesin, Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20181213 |
N/A |
ANDA |
ANDA209692 |
Rugby Laboratories, Inc. |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
40 BLISTER PACK in 1 CARTON (0536-1161-37) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 37808-733-20 |
37808-733 |
HUMAN OTC DRUG |
Mucus Relief DM |
Guaifenesin, Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20230228 |
N/A |
ANDA |
ANDA209692 |
H E B |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE, PLASTIC in 1 BOX (37808-733-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
| 37808-733-40 |
37808-733 |
HUMAN OTC DRUG |
Mucus Relief DM |
Guaifenesin, Dextromethorphan HBr |
TABLET, EXTENDED RELEASE |
ORAL |
20230228 |
N/A |
ANDA |
ANDA209692 |
H E B |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
1 BOTTLE, PLASTIC in 1 BOX (37808-733-40) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
| 59726-833-20 |
59726-833 |
HUMAN OTC DRUG |
Mucus DM Extended Release |
Dextromethorphan Hydrobromide and Guaifenesin |
TABLET |
ORAL |
20190101 |
20260201 |
ANDA |
ANDA209692 |
P & L Development, LLC |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
20 BLISTER PACK in 1 CARTON (59726-833-20) / 1 TABLET in 1 BLISTER PACK |
| 72476-734-14 |
72476-734 |
HUMAN OTC DRUG |
Mucus Relief DM |
Guaifenesin, Dextromethorphan HBr |
TABLET |
ORAL |
20191129 |
N/A |
ANDA |
ANDA209692 |
Care One (Retail Business Services, LLC.) |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
14 BLISTER PACK in 1 CARTON (72476-734-14) / 1 TABLET in 1 BLISTER PACK |
| 70000-0464-1 |
70000-0464 |
HUMAN OTC DRUG |
Mucus Relief DM Extended Release Caplets |
Guaifenesin, Dextromethorphan HBr |
TABLET |
ORAL |
20181231 |
N/A |
ANDA |
ANDA209692 |
Cardinal Health (Leader) 70000 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
28 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK |
| 70000-0464-2 |
70000-0464 |
HUMAN OTC DRUG |
Mucus Relief DM Extended Release Caplets |
Guaifenesin, Dextromethorphan HBr |
TABLET |
ORAL |
20181231 |
N/A |
ANDA |
ANDA209692 |
Cardinal Health (Leader) 70000 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
60 mg/1; 1200 mg/1 |
14 BLISTER PACK in 1 CARTON (70000-0464-2) / 1 TABLET in 1 BLISTER PACK |
| 70000-0491-1 |
70000-0491 |
HUMAN OTC DRUG |
Mucus Relief DM |
Guaifenesin, Dextromethorphan HBr |
TABLET |
ORAL |
20190131 |
N/A |
ANDA |
ANDA209692 |
Cardinal Health (Leader) 70000 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
30 mg/1; 600 mg/1 |
20 BLISTER PACK in 1 CARTON (70000-0491-1) / 1 TABLET in 1 BLISTER PACK |