Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE
Generic (ANDA)ANDA 206986RX ALVOGEN
At a glance
Jan 21, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 21, 2020
6 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE
Strength
10MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 206986
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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.
