Orange Book product · Brand (NDA)
GABITRIL
TIAGABINE HYDROCHLORIDE
Brand (NDA)NDA 020646TE ABRX CEPHALON
At a glance
Apr 16, 1999
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 16, 1999
27 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TIAGABINE HYDROCHLORIDE
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020646
Product number
005
Marketing status
RX
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
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.
