FDA Orange Book · active-ingredient family
Acetaminophen; benzhydrocodone hydrochloride
Acetaminophen; benzhydrocodone hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:APADAZ · NDA 208653
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APADAZRLD×3 | ZEVRA THERAP | NDA 208653 | — | Jan 04, 2019 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9132125 | Jul 01, 2030 | in 4 yr 1 mo | SubstanceProductU-2249 |
| 8828978 | Jul 01, 2030 | in 4 yr 1 mo | Product |
| 8748413 | Jul 01, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 9549923 | Jul 01, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 8461137 | Feb 22, 2031 | in 4 yr 9 mo | SubstanceProduct |
Acetaminophen; benzhydrocodone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
