FDA.reportPublic FDA data

Application 211858

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINETABLET, DELAYED RELEASE;ORAL1.2GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-274MesalamineMesalamineGolden State Medical Supply, Inc.ANDACurrent
51407-274MesalamineMesalamineGolden State Medical Supply, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-175MesalamineMesalamineSun Pharmaceutical Industries, Inc.ANDACurrent