FDA.reportPublic FDA data

Application 214781

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL30MG;600MGNoNo
002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL60MG;1.2GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11822-9996Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromideRITE-AIDANDACurrent
11822-9996Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromideRITE-AIDANDACurrent
30142-948GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBrKroger CompanyANDACurrent
30142-963GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBrKroger CompanyANDACurrent
41415-998Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HbrPUBLIX SUPER MARKETS, INCANDACurrent
41415-999Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrPUBLIX SUPER MARKETS, INCANDACurrent
41415-999Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrPUBLIX SUPER MARKETS, INCANDACurrent
51316-600Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideCVS PHARMACY, INCANDACurrent
51660-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-301Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-301Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
63304-106Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-106Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
68196-997Guaifenesin and Dextromethorphan Hydrobromideguaifenesin and dextromethorphan hydrobromideSAM'S WEST INCANDACurrent