FDA Orange Book · active-ingredient family
Aliskiren hemifumarate; amlodipine besylate
Aliskiren hemifumarate; amlodipine besylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TEKAMLO · NDA 022545
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEKAMLO×4 | NOVARTIS | NDA 022545 | — | Aug 26, 2010 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8613949 | Dec 21, 2029 | in 3 yr 7 mo | Product |
Aliskiren hemifumarate; amlodipine besylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
