FDA.reportPublic FDA data

Application 090886

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISEDRONATE SODIUMRISEDRONATE SODIUMTABLET;ORAL5MGNoNo
002RISEDRONATE SODIUMRISEDRONATE SODIUMTABLET;ORAL30MGNoNo
003RISEDRONATE SODIUMRISEDRONATE SODIUMTABLET;ORAL35MGNoNo
004RISEDRONATE SODIUMRISEDRONATE SODIUMTABLET;ORAL75MGNoNo
005RISEDRONATE SODIUMRISEDRONATE SODIUMTABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-666risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-666risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-666risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-667risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-667risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-667risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-668risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-668risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-668risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-727risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-727risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-727risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-928risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-928risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
47335-928risedronate sodiumrisedronate sodiumSun Pharmaceutical Industries, Inc.ANDACurrent