| 16837-298-65 |
16837-298 |
HUMAN OTC DRUG |
Pepcid Complete |
Famotidine, Calcium carbonate, and Magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20200615 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
2500 POUCH in 1 CARTON (16837-298-65) / 1 TABLET, CHEWABLE in 1 POUCH |
| 16837-298-67 |
16837-298 |
HUMAN OTC DRUG |
Pepcid Complete |
Famotidine, Calcium carbonate, and Magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20200615 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
4 POUCH in 1 CARTON (16837-298-67) / 1 TABLET, CHEWABLE in 1 POUCH |
| 16837-891-25 |
16837-891 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20090301 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
25 TABLET, CHEWABLE in 1 BOTTLE (16837-891-25) |
| 16837-891-70 |
16837-891 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20250829 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
70 TABLET, CHEWABLE in 1 BOTTLE (16837-891-70) |
| 16837-891-50 |
16837-891 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20090301 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
50 TABLET, CHEWABLE in 1 BOTTLE (16837-891-50) |
| 16837-891-65 |
16837-891 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20240111 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
25 TABLET, CHEWABLE in 1 BOTTLE (16837-891-65) |
| 16837-891-66 |
16837-891 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20231214 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
50 TABLET, CHEWABLE in 1 BOTTLE (16837-891-66) |
| 67751-202-01 |
67751-202 |
HUMAN OTC DRUG |
Pepcid Complete |
Famotidine, Calcium carbonate, and Magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20200806 |
N/A |
NDA |
NDA020958 |
Navajo Manufacturing Company Inc |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
1 POUCH in 1 CARTON (67751-202-01) / 1 TABLET, CHEWABLE in 1 POUCH |
| 67751-202-02 |
67751-202 |
HUMAN OTC DRUG |
Pepcid Complete |
Famotidine, Calcium carbonate, and Magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20200806 |
N/A |
NDA |
NDA020958 |
Navajo Manufacturing Company Inc |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
2 POUCH in 1 CARTON (67751-202-02) / 1 TABLET, CHEWABLE in 1 POUCH |