FDA.reportPublic FDA data

Application 078270

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CICLOPIROXCICLOPIROXSOLUTION;TOPICAL8%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-475CiclopiroxCiclopiroxRebel Distributors Corp.ANDACurrent
50383-419CiclopiroxCiclopiroxHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-419CiclopiroxCiclopiroxAkornANDACurrent
50383-419CiclopiroxCiclopiroxHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-419CiclopiroxCiclopiroxAkornANDACurrent
50383-419CiclopiroxCiclopiroxAkornANDACurrent
50383-419CiclopiroxCiclopiroxHi-Tech Pharmacal Co., Inc.ANDACurrent
68071-4412CiclopiroxCiclopiroxNuCare Pharmaceuticals,Inc.ANDACurrent
68712-027CNL8CiclopiroxInnocutis Holdings LLCANDACurrent
68788-7138CiclopiroxCiclopiroxPreferred Pharmaceuticals Inc.ANDACurrent
68788-7138CiclopiroxCiclopiroxPreferred Pharmaceuticals Inc.ANDACurrent
68788-7138CiclopiroxCiclopiroxPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9136ORIG2007-09-25