Orange Book product · Brand (NDA)
FEMSTAT
BUTOCONAZOLE NITRATE
Brand (NDA)NDA 019359DISCN ROCHE PALO
At a glance
Nov 25, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 1985
41 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BUTOCONAZOLE NITRATE
Strength
100MG
Dosage form
SUPPOSITORY
Route
VAGINAL
TE code
Not listed
Application
NDA 019359
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active 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.
