FDA.reportPublic FDA data

Application 076387

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOTRIMAZOLECLOTRIMAZOLETROCHE/LOZENGE;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4146ClotrimazoleClotrimazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4146ClotrimazoleClotrimazoleHikma Pharmacuticals USA USA Inc.ANDACurrent
0054-4146ClotrimazoleClotrimazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8146ClotrimazoleClotrimazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8146ClotrimazoleClotrimazoleHikma Pharmacuticals USA USA Inc.ANDACurrent
0054-8146ClotrimazoleClotrimazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
55154-4951ClotrimazoleClotrimazoleCardinal HealthANDACurrent
55154-4951ClotrimazoleClotrimazoleCardinal HealthANDACurrent
55154-4951ClotrimazoleClotrimazoleCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43071ORIG2006-10-26
8904ORIG2004-07-30