FDA Orange Book · active-ingredient family
Amoxicillin; clarithromycin; lansoprazole
Amoxicillin; clarithromycin; lansoprazole 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:PREVPAC (COPACKAGED) · NDA 050757
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, capsule, delayed rel pellets
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREVPAC (COPACKAGED)RLD | TAKEDA PHARMS USA | NDA 050757 | — | Dec 02, 1997 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | RISING | ANDA 206006 | AB | Oct 07, 2016 | |
| LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | SANDOZ | ANDA 202588 | AB | Mar 04, 2014 | |
| LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | ANI PHARMS | ANDA 200218 | — | Aug 30, 2013 |
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; lansoprazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
