FDA Orange Book · active-ingredient family
Aclidinium bromide
Aclidinium bromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TUDORZA PRESSAIR · NDA 202450
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TUDORZA PRESSAIRRLD | AZURITY | NDA 202450 | — | Jul 23, 2012 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10085974 | Mar 13, 2029 | in 2 yr 9 mo | ProductU-2513 |
| 11000517 | Mar 13, 2029 | in 2 yr 9 mo | ProductU-2513 |
Aclidinium bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
