Orange Book product · Brand (NDA)
TERCONAZOLE
TERCONAZOLE
At a glance
Oct 01, 2004
Approved
Brand (NDA)
Application
BX
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 01, 2004
22 yr ago
Today
Pharmaceutical detail
Active ingredient
TERCONAZOLE
Strength
0.8%
Dosage form
CREAM
Route
VAGINAL
TE code
BX
Application
NDA 021735
Product number
001
Marketing status
RX
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.
- 1991TERAZOL 3Brand (NDA)
NDA 019964 · JANSSEN PHARMS
- 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.
