| 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) |
| 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) |
| 16837-891-72 |
16837-891 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20260529 |
N/A |
NDA |
NDA020958 |
Kenvue Brands LLC |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
72 TABLET, CHEWABLE in 1 BOTTLE (16837-891-72) |
| 29485-6522-2 |
29485-6522 |
HUMAN OTC DRUG |
DUAL ACTION Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable |
TABLET, CHEWABLE |
ORAL |
20200729 |
N/A |
NDA |
NDA020958 |
Lil' Drug Store Products, Inc. |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
2 POUCH in 1 CARTON (29485-6522-2) / 1 TABLET, CHEWABLE in 1 POUCH |
| 70264-034-01 |
70264-034 |
HUMAN OTC DRUG |
Pepcid Complete |
famotidine, calcium carbonate, and magnesium hydroxide |
TABLET, CHEWABLE |
ORAL |
20221228 |
N/A |
NDA |
NDA020958 |
R J General Corporation |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
50 TABLET, CHEWABLE in 1 CARTON (70264-034-01) |
| 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 |
| 66715-6422-7 |
66715-6422 |
HUMAN OTC DRUG |
Pepcid Complete |
Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet |
TABLET, CHEWABLE |
ORAL |
20220419 |
N/A |
NDA |
NDA020958 |
Lil' Drug Store Products, Inc. |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
25 POUCH in 1 BOX, UNIT-DOSE (66715-6422-7) / 1 TABLET, CHEWABLE in 1 POUCH |
| 66715-6422-8 |
66715-6422 |
HUMAN OTC DRUG |
Pepcid Complete |
Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet |
TABLET, CHEWABLE |
ORAL |
20220419 |
N/A |
NDA |
NDA020958 |
Lil' Drug Store Products, Inc. |
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
800 mg/1; 10 mg/1; 165 mg/1 |
30 POUCH in 1 BOX, UNIT-DOSE (66715-6422-8) / 1 TABLET, CHEWABLE in 1 POUCH |