FDA Orange Book · active-ingredient family
Aluminum hydroxide; magnesium trisilicate
Aluminum hydroxide; magnesium trisilicate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GAVISCON · NDA 018685
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GAVISCONRLD×2 | CHATTEM SANOFI | NDA 018685 | — | Dec 09, 1983 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOAMICON | NOVARTIS | ANDA 072687 | — | Jun 28, 1989 | |
| ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE | PENNEX | ANDA 089449 | — | Nov 27, 1987 | |
| FOAMCOAT | GUARDIAN DRUG | ANDA 071793 | — | Sep 04, 1987 |
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.
Aluminum hydroxide; magnesium trisilicate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
