Orange Book product · Generic (ANDA)
ASENAPINE MALEATE
ASENAPINE MALEATE
Generic (ANDA)ANDA 206107TE ABRX SIGMAPHARM LABS LLC
At a glance
Dec 10, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 10, 2020
5 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ASENAPINE MALEATE
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
SUBLINGUAL
TE code
AB
Application
ANDA 206107
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ASENAPINE MALEATE
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.
