Application 089853

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-951CHLORZOXAZONECHLORZOXAZONEQuality Care Products, LLCANDACurrent
55700-951CHLORZOXAZONECHLORZOXAZONEQuality Care Products, LLCANDACurrent
59651-306CHLORZOXAZONECHLORZOXAZONEAurobindo Pharma LimitedANDACurrent
59651-306CHLORZOXAZONECHLORZOXAZONEAurobindo Pharma LimitedANDACurrent
71205-711CHLORZOXAZONECHLORZOXAZONEProficient Rx LPANDACurrent
71335-2009CHLORZOXAZONECHLORZOXAZONEBryant Ranch PrepackANDACurrent