FDA.reportPublic FDA data

Application 091103

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESZOPICLONEESZOPICLONETABLET;ORAL1MGNoNo
002ESZOPICLONEESZOPICLONETABLET;ORAL2MGNoNo
003ESZOPICLONEESZOPICLONETABLET;ORAL3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-828ESZOPICLONEESZOPICLONEMedsource PharmaceuticalsANDACurrent
45865-828ESZOPICLONEESZOPICLONEMedsource PharmaceuticalsANDACurrent
45865-829ESZOPICLONEESZOPICLONEMedsource PharmaceuticalsANDACurrent
45865-829ESZOPICLONEESZOPICLONEMedsource PharmaceuticalsANDACurrent
45865-830ESZOPICLONEESZOPICLONEMedsource PharmaceuticalsANDACurrent
45865-830ESZOPICLONEESZOPICLONEMedsource PharmaceuticalsANDACurrent
47335-586ESZOPICLONEESZOPICLONESun Pharmaceutical Industries, Inc.ANDACurrent
47335-587ESZOPICLONEESZOPICLONESun Pharmaceutical Industries, Inc.ANDACurrent
47335-588ESZOPICLONEESZOPICLONESun Pharmaceutical Industries, Inc.ANDACurrent
50436-5537ESZOPICLONEESZOPICLONEUnit Dose ServicesANDACurrent
61919-500ESZOPICLONEESZOPICLONEDirect RxANDACurrent
61919-500ESZOPICLONEESZOPICLONEDirect RxANDACurrent
61919-502ESZOPICLONEESZOPICLONEDIRECT RXANDACurrent
63629-5319ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
63629-5319ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
63629-5319ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
63629-5319ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
63629-5325ESZOPICLONEESZOPICLONEBryant Ranch PrepackANDACurrent
68788-9296ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9824ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals Inc.ANDACurrent
68788-9991ESZOPICLONEESZOPICLONEPreferred Pharmaceuticals, Inc.ANDACurrent