Orange Book product · Brand (NDA)
LAMPRENE
CLOFAZIMINE
Brand (NDA)NDA 019500DISCN NOVARTIS
At a glance
Dec 15, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 1986
40 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOFAZIMINE
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 019500
Product number
002
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.
