Orange Book product · Brand (NDA)
PENLAC
CICLOPIROX
At a glance
Dec 17, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 1999
26 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CICLOPIROX
Strength
8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 021022
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.
- 2003LOPROXBrand (NDA)
NDA 021159 · BAUSCH
- 1997CICLOPIROXBrand (NDA)
NDA 020519 · ALVOGEN
- 1988LOPROXBrand (NDA)
NDA 019824 · EUROFARMA
- 1982LOPROXBrand (NDA)
NDA 018748 · EUROFARMA
- 2018CICLOPIROXGeneric (ANDA)
ANDA 209975 · ENCUBE
- 2012CICLOPIROXGeneric (ANDA)
ANDA 091595 · GLENMARK PHARMS
- 2011CICLOPIROXGeneric (ANDA)
ANDA 090269 · SUN PHARMA CANADA
- 2010CICLOPIROXGeneric (ANDA)
ANDA 078463 · COSETTE PHARMS NC
- 2010CICLOPIROXGeneric (ANDA)
ANDA 090146 · FOUGERA PHARMS
- 2010CICLOPIROXGeneric (ANDA)
ANDA 078975 · EPIC PHARMA LLC
- 2010CICLOPIROXGeneric (ANDA)
ANDA 078594 · PADAGIS US
- 2009CICLOPIROXGeneric (ANDA)
ANDA 090490 · ACTAVIS MID ATLANTIC
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.
