Orange Book product · Brand (NDA)
SULFAMYLON
MAFENIDE ACETATE
Brand (NDA)NDA 016763RX RISING
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MAFENIDE ACETATE
Strength
EQ 85MG BASE/GM
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 016763
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.
