Orange Book product · Brand (NDA)
TERAZOL 3
TERCONAZOLE
At a glance
Feb 21, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 21, 1991
35 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TERCONAZOLE
Strength
0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
NDA 019964
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.
- 2004TERCONAZOLEBrand (NDA)
NDA 021735 · FOUGERA PHARMS INC
- 1988TERAZOL 3Brand (NDA)
NDA 019641 · JANSSEN PHARMS
- 1987TERAZOL 7Brand (NDA)
NDA 019579 · JANSSEN PHARMS
- 2007TERCONAZOLEGeneric (ANDA)
ANDA 077553 · SUN PHARMA CANADA
- 2006TERCONAZOLEGeneric (ANDA)
ANDA 076850 · FOUGERA PHARMS
- 2006TERCONAZOLEGeneric (ANDA)
ANDA 077149 · PADAGIS ISRAEL
- 2005TERCONAZOLEGeneric (ANDA)
ANDA 076712 · FOUGERA PHARMS
- 2005TERCONAZOLEGeneric (ANDA)
ANDA 076043 · SUN PHARMA CANADA
- 2004TERCONAZOLEGeneric (ANDA)
ANDA 075953 · SUN PHARMA CANADA
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.
