FDA.reportPublic FDA data

Application 205215

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE;ORAL25MGNoNo
002INDOMETHACININDOMETHACINCAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59746-346IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-346IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-346IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-346IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-347IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-347IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-347IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-347IndomethacinindomethacinJubilant Cadista Pharmaceuticals Inc.ANDACurrent