FDA.report

Application 202706

Type
ANDA
Sponsor
JUBILANT GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE, EXTENDED RELEASE;ORAL75MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
52959-082INDOMETHACIN EXTENDED-RELEASEINDOMETHACIN EXTENDED-RELEASEH. J. Harkins Company inc.ANDACurrent
59746-379Indomethacin extended-releaseIndomethacin extended-releaseJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-379Indomethacin extended-releaseIndomethacin extended-releaseJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-379Indomethacin extended-releaseIndomethacin extended-releaseJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-379Indomethacin extended-releaseIndomethacin extended-releaseJubilant Cadista Pharmaceuticals Inc.ANDACurrent
68071-3174Indomethacin extended-releaseIndomethacin extended-releaseNuCare Pharmaceuticals, Inc.ANDACurrent
71335-0137Indomethacin extended-releaseIndomethacin extended-releaseBryant Ranch PrepackANDACurrent
71335-0137Indomethacin extended-releaseIndomethacin extended-releaseBryant Ranch PrepackANDACurrent
71335-0137Indomethacin extended-releaseIndomethacin extended-releaseBryant Ranch PrepackANDACurrent