Orange Book product · Brand (NDA)
EXELDERM
SULCONAZOLE NITRATE
Brand (NDA)NDA 018738RX JOURNEY
At a glance
Aug 30, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 1985
41 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
SULCONAZOLE NITRATE
Strength
1%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 018738
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.
