FDA Orange Book · active-ingredient family
Magnesium hydroxide; omeprazole; sodium bicarbonate
Magnesium hydroxide; omeprazole; sodium bicarbonate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE · NDA 022456
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE×2 | SANTARUS | NDA 022456 | — | Dec 04, 2009 | |
| ZEGERID×2 | SANTARUS | NDA 021850 | — | Mar 24, 2006 |
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.
Magnesium hydroxide; omeprazole; sodium bicarbonate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
