Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE
Generic (ANDA)ANDA 208269TE ABRX ALVOGEN
At a glance
Mar 01, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 01, 2021
5 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE
Strength
20MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 208269
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCODONE BITARTRATE
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.

