Orange Book product · Brand (NDA)
FEMSTAT 3
BUTOCONAZOLE NITRATE
Brand (NDA)NDA 020421DISCN BAYER
At a glance
Dec 21, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 1995
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BUTOCONAZOLE NITRATE
Strength
2%
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
NDA 020421
Product number
001
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.
