Orange Book product
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE 800MG;10MG;165MG
Orange Book ANDA 077355 · PERRIGO R AND D CO · Over the counter
Key facts
| Proprietary name | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE |
|---|---|
| Active ingredients | CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE |
| Strength | 800MG;10MG;165MG |
| Dosage form | TABLET, CHEWABLE |
| Route | ORAL |
| Application | ANDA077355 |
| Applicant holder | PERRIGO R AND D CO |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 6, 2008 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.