Orange Book product · Brand (NDA)
VAGISTAT-1
TIOCONAZOLE
Brand (NDA)NDA 020676OTC COMBE
At a glance
Feb 11, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 11, 1997
29 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
TIOCONAZOLE
Strength
6.5%
Dosage form
OINTMENT
Route
VAGINAL
TE code
Not listed
Application
NDA 020676
Product number
001
Marketing status
OTC
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.
