ciclopirox Topical Solution

Brand(s)
CNL8, Ciclodan, Penlac Nail Lacquer
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Perrigo New York Inc (2015-10-06)
Oldest Current Product
2007-05-22
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
TOPICAL SOLUTION\CICLOPIROX
FDAOB
TOPICAL\SOLUTION\CICLOPIROX
SPL Active
TOPICAL\SOLUTION\CICLOPIROX
TOPICAL\SOLUTION\CICLOPIROX: TOCOPHEROL
SPL Moiety
TOPICAL\SOLUTION\CICLOPIROX
TOPICAL\SOLUTION\CICLOPIROX: TOCOPHEROL

product(s) by strength(s)

ciclopirox 80 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001875180Penlac Nail LacquerNDAValeant Pharmaceuticals North America Llc2013-05-01CICLOPIROXTOPICALSOLUTIONNDA0210229793245c-c3e0-4351-a2ab-b54b46aecb43
2421920705UNAPPROVED DRUG OTHER MARKETING CATEGORYAcella Pharmaceuticals, Llc2009-07-01CICLOPIROX, TOCOPHEROLTOPICALSOLUTION814d7c39-a917-43c3-bb6b-efce322607e0

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130317ANDAG&W Laboratories, Inc.2007-05-22CICLOPIROXTOPICALSOLUTIONANDA0782333ef301b7-c40a-0635-4a76-185141473dba
2007817106ANDASandoz Inc2007-09-18CICLOPIROXTOPICALSOLUTIONANDA0776876350a31e-4299-4ed7-b5b7-aaf4d1fc66b7
3435380500CiclodanANDAMedimetriks Pharmaceuticals Inc2011-04-10CICLOPIROXTOPICALSOLUTIONANDA078233246676e5-60a0-41dc-b665-30d5e670b426
4435380501CiclodanANDAMedimetriks Pharmaceuticals Inc2011-04-10CICLOPIROXTOPICALSOLUTIONANDA078233246676e5-60a0-41dc-b665-30d5e670b426
5458020141ANDAPerrigo New York Inc2007-09-19CICLOPIROXTOPICALSOLUTIONANDA07762302f46b6e-b424-4210-83bf-e79618df4344
6503830419ANDAHi-Tech Pharmacal Co., Inc.2007-09-18CICLOPIROXTOPICALSOLUTIONANDA0782704439cb3d-6825-4558-a981-122ec15f7b05
7617480200ANDAVersapharm Incorporated2010-03-20CICLOPIROXTOPICALSOLUTIONANDA0789755a562e2c-ac56-4e83-89b0-fe625e4c5e1d
8674050450ANDAHarris Pharmaceutical, Inc.2007-09-19CICLOPIROXTOPICALSOLUTIONANDA07823370495a7c-08b7-6623-c208-b1b5fa731781
9687120027CNL8ANDAInnocutis2008-10-31CICLOPIROXTOPICALSOLUTIONANDA07827068955ba2-590f-4460-994e-bc481aed3d23

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686064ANDAPhysicians Total Care, Inc.2009-09-04CICLOPIROXTOPICALSOLUTION000936179ANDA0780795fa1e0b6-3836-4d56-99ee-0545908ee405

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950475ANDARebel Distributors Corp2007-09-18CICLOPIROXTOPICALSOLUTION503830419ANDA078270ee775b56-0575-41e4-a948-c92a0bcd69b6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077623CICLOPIROXPERRIGO NEW YORK INC2007-09-18ANDA077623_001
2ANDA077687CICLOPIROXTOLMAR INC2007-09-18ANDA077687_001
3ANDA078046CICLOPIROXACTAVIS MID ATLANTIC LLC2007-09-18ANDA078046_001
4ANDA078079CICLOPIROXTrueTEVA PHARMACEUTICALS USA2007-09-18ANDA078079_001
5ANDA078124CICLOPIROXCIPLA LTD2007-09-18ANDA078124_001
6ANDA078144CICLOPIROXTARO PHARMACEUTICAL INDUSTRIES LTD2007-09-18ANDA078144_001
7ANDA078172CICLOPIROXAPOTEX INC2007-09-18ANDA078172_001
8ANDA078233CICLOPIROXG AND W LABORATORIES INC2007-09-18ANDA078233_001
9ANDA078270CICLOPIROXHI TECH PHARMACAL CO INC2007-09-18ANDA078270_001
10ANDA078567CICLOPIROXTrueMYLAN PHARMACEUTICALS INC2007-09-18ANDA078567_001
11ANDA078975CICLOPIROXVERSAPHARM INC2010-02-17ANDA078975_001
12NDA021022PENLACVALEANT INTERNATIONAL BERMUDA1999-12-17NDA021022_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077623_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
2ANDA077687_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
3ANDA078046_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
4ANDA078079_001discontinuedCICLOPIROX (8%)TOPICALSOLUTIONFalse2007-09-18CICLOPIROX
5ANDA078124_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
6ANDA078144_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
7ANDA078172_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
8ANDA078233_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
9ANDA078270_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2007-09-18CICLOPIROX
10ANDA078567_001discontinuedCICLOPIROX (8%)TOPICALSOLUTIONFalse2007-09-18CICLOPIROX
11ANDA078975_001RXCICLOPIROX (8%)TOPICALSOLUTIONFalseAT2010-02-17CICLOPIROX
12NDA021022_001RXCICLOPIROX (8%)TOPICALSOLUTIONTrueAT1999-12-17PENLAC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102f46b6e-b424-4210-83bf-e79618df4344 (view SPL)Ciclopirox Topical Solution, 8%prescriptionHuman PrescriptionPerrigo New York Inc2015-10-062458020141
2246676e5-60a0-41dc-b665-30d5e670b426 (view SPL)Ciclodan Ciclopirox Topical Solution, 8% (Nail Lacquer)prescriptionHuman PrescriptionMedimetriks Pharmaceuticals IncMANUFACTURE2011-03-291435380500, 435380501
32c67dd09-ab1f-4ccf-97b5-421356f64f22 (view SPL)Ciclopirox Treatment KitprescriptionHuman PrescriptionAcella Pharmaceuticals, Llc2013-04-011421920714
43ef301b7-c40a-0635-4a76-185141473dba (view SPL)Ciclopirox Topical Solution, 8% (Nail Lacquer)Rx Only For use on fingernails and toenails and immediately adjacent skin onlyNot for use in eyesprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2011-09-075007130317
54439cb3d-6825-4558-a981-122ec15f7b05 (view SPL)Ciclopirox Topical Solution, 8% (Nail Lacquer)prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2011-11-182503830419
65a562e2c-ac56-4e83-89b0-fe625e4c5e1d (view SPL)Ciclopirox Topical Solution, 8% (Nail Lacquer)prescriptionHuman PrescriptionVersapharm Incorporated2014-11-123617480200
75fa1e0b6-3836-4d56-99ee-0545908ee405 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-191548686064
86350a31e-4299-4ed7-b5b7-aaf4d1fc66b7 (view SPL)Ciclopirox Topical Solution, 8% (Nail Lacquer)prescriptionHuman PrescriptionSandoz IncANALYSIS, MANUFACTURE2010-02-083007817106
968955ba2-590f-4460-994e-bc481aed3d23 (view SPL)CNL8 (ciclopirox topical solution 8%)Nail LacquerprescriptionHuman PrescriptionInnocutis2011-12-013687120027
1070495a7c-08b7-6623-c208-b1b5fa731781 (view SPL)For use on fingernails and toenails and immediately adjacent skin onlyNot for use in eyesprescriptionHuman PrescriptionHarris Pharmaceutical, Inc.2009-11-271674050450
11814d7c39-a917-43c3-bb6b-efce322607e0 (view SPL)Ciclopirox Topical Solution, 8% Kit Ciclopirox Topical Solution, 8% (Nail Lacquer) Swabplus nail lacquer remover Emery boardprescriptionHuman PrescriptionAcella Pharmaceuticals, Llc2012-11-011421920705
129793245c-c3e0-4351-a2ab-b54b46aecb43 (view SPL)Penlac Nail Lacquer(ciclopirox) Topical Solution, 8%prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2013-05-011001875180
13ee775b56-0575-41e4-a948-c92a0bcd69b6 (view SPL)Ciclopirox Topical Solution, 8% (Nail Lacquer)prescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-10-091216950475

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII