Orange Book product · Generic (ANDA)
CICLOPIROX
CICLOPIROX
At a glance
Apr 05, 2018
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 05, 2018
8 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CICLOPIROX
Strength
1%
Dosage form
SHAMPOO
Route
TOPICAL
TE code
AT
Application
ANDA 209975
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CICLOPIROX
- 2003LOPROXBrand (NDA)
NDA 021159 · BAUSCH
- 1999PENLACBrand (NDA)
NDA 021022 · VALEANT BERMUDA
- 1997CICLOPIROXBrand (NDA)
NDA 020519 · ALVOGEN
- 1988LOPROXBrand (NDA)
NDA 019824 · EUROFARMA
- 1982LOPROXBrand (NDA)
NDA 018748 · EUROFARMA
- 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.
