FDA Orange Book · active-ingredient family
Calcium carbonate; famotidine; magnesium hydroxide
Calcium carbonate; famotidine; magnesium hydroxide is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PEPCID COMPLETE · NDA 020958
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PEPCID COMPLETERLD | KENVUE BRANDS | NDA 020958 | — | Oct 16, 2000 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | PERRIGO R AND D | ANDA 204782 | — | Aug 29, 2016 | |
| FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | PERRIGO R AND D | ANDA 077355 | — | Feb 06, 2008 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Calcium carbonate; famotidine; magnesium hydroxide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
