Orange Book product · Brand (NDA)
SULAR
NISOLDIPINE
Brand (NDA)NDA 020356TE ABRX AZURITY
At a glance
Jan 02, 2008
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 02, 2008
18 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NISOLDIPINE
Strength
8.5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 020356
Product number
008
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
