Orange Book product · Brand (NDA)
OBREDON
GUAIFENESIN; HYDROCODONE BITARTRATE
At a glance
Nov 14, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2014
11 yr 9 mo ago
Today
Patent 10105324 expires
Listed drug substance patent expiration.
Nov 13, 2035
in 9 yr 6 mo
Patent 9549907 expires
Listed drug substance patent expiration.
Nov 13, 2035
in 9 yr 6 mo
Patent 9808431 expires
Listed drug substance patent expiration.
Nov 13, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
GUAIFENESIN; HYDROCODONE BITARTRATE
Strength
200MG/5ML;2.5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 205474
Product number
001
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 (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10105324 | Nov 13, 2035 | in 9 yr 6 mo | SubstanceProductU-2023 |
| 9549907 | Nov 13, 2035 | in 9 yr 6 mo | SubstanceProductU-2023 |
| 9808431 | Nov 13, 2035 | in 9 yr 6 mo | SubstanceProductU-2023 |
