Orange Book product · Generic (ANDA)
TAPENTADOL HYDROCHLORIDE
TAPENTADOL HYDROCHLORIDE
Generic (ANDA)ANDA 219119RX NOVITIUM PHARMA
At a glance
Jan 26, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
TAPENTADOL HYDROCHLORIDE
Strength
EQ 20MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 219119
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TAPENTADOL HYDROCHLORIDE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
