FDA Orange Book · active-ingredient family
Amoxicillin; clarithromycin; omeprazole
Amoxicillin; clarithromycin; omeprazole is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OMECLAMOX-PAK · NDA 050824
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, capsule, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMECLAMOX-PAKRLD | CUMBERLAND | NDA 050824 | — | Feb 08, 2011 |
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.
Amoxicillin; clarithromycin; omeprazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
