Orange Book product · Brand (NDA)
APADAZ
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
At a glance
Jan 04, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 04, 2019
7 yr 7 mo ago
Today
Patent 8748413 expires
Listed drug substance patent expiration.
Jul 01, 2030
in 4 yr 1 mo
Patent 8828978 expires
Listed drug product patent expiration.
Jul 01, 2030
in 4 yr 1 mo
Patent 9132125 expires
Listed drug substance patent expiration.
Jul 01, 2030
in 4 yr 1 mo
Patent 9549923 expires
Listed drug substance patent expiration.
Jul 01, 2030
in 4 yr 1 mo
Patent 8461137 expires
Listed drug substance patent expiration.
Feb 22, 2031
in 4 yr 9 mo
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Strength
325MG;EQ 4.08MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208653
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8748413 | Jul 01, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 8828978 | Jul 01, 2030 | in 4 yr 1 mo | Product |
| 9132125 | Jul 01, 2030 | in 4 yr 1 mo | SubstanceProductU-2249 |
| 9549923 | Jul 01, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 8461137 | Feb 22, 2031 | in 4 yr 9 mo | SubstanceProduct |
