Orange Book product · Brand (NDA)
ANZEMET
DOLASETRON MESYLATE
Brand (NDA)NDA 020624DISCN VALIDUS PHARMS
At a glance
Sep 11, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 11, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DOLASETRON MESYLATE
Strength
100MG/5ML (20MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020624
Product number
001
Marketing status
DISCN
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.
