FDA.reportPublic FDA data

Application 212053

Type
ANDA
Sponsor
I3 PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52817-230CHLORZOXAZONECHLORZOXAZONETruPharma, LLCANDACurrent
52817-230CHLORZOXAZONECHLORZOXAZONETruPharma, LLCANDACurrent
52817-231CHLORZOXAZONECHLORZOXAZONETruPharma, LLCANDACurrent
52817-231CHLORZOXAZONECHLORZOXAZONETruPharma, LLCANDACurrent
72319-168CHLORZOXAZONECHLORZOXAZONEi3 Pharmaceuticals, LLCANDACurrent
72319-168CHLORZOXAZONECHLORZOXAZONEi3 Pharmaceuticals, LLCANDACurrent
72319-169CHLORZOXAZONECHLORZOXAZONEi3 Pharmaceuticals, LLCANDACurrent
72319-169CHLORZOXAZONECHLORZOXAZONEi3 Pharmaceuticals, LLCANDACurrent