FDA.reportPublic FDA data

Application 211849

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORZOXAZONECHLORZOXAZONETABLET;ORAL375MGNoNo
002CHLORZOXAZONECHLORZOXAZONETABLET;ORAL500MGNoNo
003CHLORZOXAZONECHLORZOXAZONETABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-338ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-338ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-338ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-339ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-339ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-339ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-339ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-340ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-340ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-340ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent
51862-340ChlorzoxazonechlorzoxazoneMayne PharmaANDACurrent