Orange Book product · Generic (ANDA)
GYNAZOLE-1
BUTOCONAZOLE NITRATE
Generic (ANDA)ANDA 200923RX PADAGIS ISRAEL
At a glance
May 18, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 18, 2012
14 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
BUTOCONAZOLE NITRATE
Strength
2%
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
ANDA 200923
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of BUTOCONAZOLE NITRATE
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.
