| 25000-042-01 |
25000-042 |
HUMAN OTC DRUG |
Guaifenesin 600 mg |
Guaifenesin 600 mg |
TABLET |
ORAL |
20230823 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
600 mg/1 |
1 BOTTLE in 1 CARTON (25000-042-01) / 20 TABLET in 1 BOTTLE |
| 25000-042-12 |
25000-042 |
HUMAN OTC DRUG |
Guaifenesin 600 mg |
Guaifenesin 600 mg |
TABLET |
ORAL |
20230823 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
600 mg/1 |
500 TABLET in 1 BOTTLE (25000-042-12) |
| 25000-042-55 |
25000-042 |
HUMAN OTC DRUG |
Guaifenesin 600 mg |
Guaifenesin 600 mg |
TABLET |
ORAL |
20230823 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
600 mg/1 |
2 BLISTER PACK in 1 CARTON (25000-042-55) / 10 TABLET in 1 BLISTER PACK |
| 25000-042-99 |
25000-042 |
HUMAN OTC DRUG |
Guaifenesin 600 mg |
Guaifenesin 600 mg |
TABLET |
ORAL |
20250418 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
600 mg/1 |
2 BLISTER PACK in 1 CARTON (25000-042-99) / 20 TABLET in 1 BLISTER PACK |
| 41226-724-89 |
41226-724 |
HUMAN OTC DRUG |
Maximum Strength Mucus Relief |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20240527 |
N/A |
ANDA |
ANDA217780 |
KROGER COMPANY |
GUAIFENESIN |
1200 mg/1 |
1 BLISTER PACK in 1 CARTON (41226-724-89) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 25000-041-12 |
25000-041 |
HUMAN OTC DRUG |
Guaifenesin 1200 mg |
Guaifenesin 1200 mg |
TABLET |
ORAL |
20230823 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
1200 mg/1 |
500 TABLET in 1 BOTTLE (25000-041-12) |
| 25000-041-34 |
25000-041 |
HUMAN OTC DRUG |
Guaifenesin 1200 mg |
Guaifenesin 1200 mg |
TABLET |
ORAL |
20250418 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
1200 mg/1 |
2 BLISTER PACK in 1 CARTON (25000-041-34) / 14 TABLET in 1 BLISTER PACK |
| 25000-041-75 |
25000-041 |
HUMAN OTC DRUG |
Guaifenesin 1200 mg |
Guaifenesin 1200 mg |
TABLET |
ORAL |
20230823 |
N/A |
ANDA |
ANDA217780 |
MARKSANS PHARMA LIMITED |
GUAIFENESIN |
1200 mg/1 |
2 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACK |
| 41226-723-02 |
41226-723 |
HUMAN OTC DRUG |
Mucus Relief |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20240521 |
N/A |
ANDA |
ANDA217780 |
KROGER COMPANY |
GUAIFENESIN |
600 mg/1 |
1 BLISTER PACK in 1 CARTON (41226-723-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 49483-724-70 |
49483-724 |
HUMAN OTC DRUG |
Guaifenesin Extended Release 1200 mg |
Guaifenesin |
TABLET |
ORAL |
20240108 |
N/A |
ANDA |
ANDA217780 |
TIME CAP LABORATORIES, INC. |
GUAIFENESIN |
1200 mg/1 |
70 TABLET in 1 BOTTLE (49483-724-70) |
| 51316-724-94 |
51316-724 |
HUMAN OTC DRUG |
Mucus Relief |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250526 |
N/A |
ANDA |
ANDA217780 |
CVS Pharmacy |
GUAIFENESIN |
1200 mg/1 |
2 BLISTER PACK in 1 CARTON (51316-724-94) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 49483-723-50 |
49483-723 |
HUMAN OTC DRUG |
Guaifenesin Extended Release 600 mg |
Guaifenesin |
TABLET |
ORAL |
20240108 |
N/A |
ANDA |
ANDA217780 |
TIME CAP LABORATORIES, INC. |
GUAIFENESIN |
600 mg/1 |
500 TABLET in 1 BOTTLE (49483-723-50) |
| 68196-033-56 |
68196-033 |
HUMAN OTC DRUG |
Maximum Strength Mucus Relief |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250820 |
N/A |
ANDA |
ANDA217780 |
SAM'S WEST INC |
GUAIFENESIN |
1200 mg/1 |
4 BLISTER PACK in 1 CARTON (68196-033-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 68391-724-95 |
68391-724 |
HUMAN OTC DRUG |
Mucus Relief |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250820 |
N/A |
ANDA |
ANDA217780 |
BJWC (Berkley & Jensen / BJ's) |
GUAIFENESIN |
1200 mg/1 |
1 BOTTLE in 1 CARTON (68391-724-95) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| 0536-1249-71 |
0536-1249 |
HUMAN OTC DRUG |
Mucus Relief ER |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250421 |
N/A |
ANDA |
ANDA217780 |
Rugby Laboratories |
GUAIFENESIN |
1200 mg/1 |
2 BLISTER PACK in 1 CARTON (0536-1249-71) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| 70000-0730-1 |
70000-0730 |
HUMAN OTC DRUG |
Mucus Relief |
Guaifenesin |
TABLET, EXTENDED RELEASE |
ORAL |
20250408 |
N/A |
ANDA |
ANDA217780 |
LEADER/ Cardinal Health 110, Inc. |
GUAIFENESIN |
1200 mg/1 |
2 BLISTER PACK in 1 CARTON (70000-0730-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |