Orange Book product · Brand (NDA)
SPECTAZOLE
ECONAZOLE NITRATE
At a glance
Dec 23, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1982
44 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ECONAZOLE NITRATE
Strength
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 018751
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.
- 2013ECOZABrand (NDA)
NDA 205175 · RESILIA PHARMS
- 2018ECONAZOLE NITRATEGeneric (ANDA)
ANDA 210364 · AUROBINDO PHARMA USA
- 2004ECONAZOLE NITRATEGeneric (ANDA)
ANDA 076574 · ENCUBE
- 2004ECONAZOLE NITRATEGeneric (ANDA)
ANDA 076479 · PADAGIS ISRAEL
- 2002ECONAZOLE NITRATEGeneric (ANDA)
ANDA 076075 · CHARTWELL RX
- 2002ECONAZOLE NITRATEGeneric (ANDA)
ANDA 076005 · 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.
