Orange Book product · Brand (NDA)
PRIALT
ZICONOTIDE ACETATE
Brand (NDA)NDA 021060RX ESTEVE
At a glance
Dec 28, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 28, 2004
21 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ZICONOTIDE ACETATE
Strength
500MCG/5ML (100MCG/ML)
Dosage form
INJECTABLE
Route
INTRATHECAL
TE code
Not listed
Application
NDA 021060
Product number
004
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.
