Orange Book product · Brand (NDA)
MAGNEVIST
GADOPENTETATE DIMEGLUMINE
Brand (NDA)NDA 021037DISCN BAYER HLTHCARE
At a glance
Mar 10, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 10, 2000
26 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
GADOPENTETATE DIMEGLUMINE
Strength
469.01MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 021037
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.
