Orange Book product · Brand (NDA)
IMPAVIDO
MILTEFOSINE
Brand (NDA)NDA 204684RX KNIGHT THERAPS
At a glance
Mar 19, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 19, 2014
12 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MILTEFOSINE
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 204684
Product number
001
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.
