Orange Book product · Generic (ANDA)
BUTENAFINE HYDROCHLORIDE
BUTENAFINE HYDROCHLORIDE
Generic (ANDA)ANDA 205181OTC SUN PHARMA CANADA
At a glance
Nov 16, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BUTENAFINE HYDROCHLORIDE
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
ANDA 205181
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUTENAFINE HYDROCHLORIDE
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.
