FDA.reportPublic FDA data

Application 213203

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL600MG;60MGNoNo
002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.2GM;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-9946Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClKROGER COMPANYANDACurrent
30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClKROGER COMPANYANDACurrent
58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
79481-1002Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClMeijerANDACurrent