Orange Book product · Generic (ANDA)
NISOLDIPINE
NISOLDIPINE
Generic (ANDA)ANDA 216606TE ABRX AMTA
At a glance
Apr 10, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 10, 2023
3 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
NISOLDIPINE
Strength
8.5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 216606
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NISOLDIPINE
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.
