Orange Book product · Brand (NDA)
TUDORZA PRESSAIR
ACLIDINIUM BROMIDE
Brand (NDA)NDA 202450RX AZURITY
At a glance
Jul 23, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2012
14 yr 1 mo ago
Today
Patent 10085974 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 11000517 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Pharmaceutical detail
Active ingredient
ACLIDINIUM BROMIDE
Strength
0.4MG/INH
Dosage form
POWDER, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 202450
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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 |
