Orange Book product · Brand (NDA)
LOPROX
CICLOPIROX
At a glance
Feb 28, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2003
23 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CICLOPIROX
Strength
1%
Dosage form
SHAMPOO
Route
TOPICAL
TE code
Not listed
Application
NDA 021159
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.
- 1999PENLACBrand (NDA)
NDA 021022 · VALEANT BERMUDA
- 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.
