FDA.reportPublic FDA data

Application 091549

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE, EXTENDED RELEASE;ORAL75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-919IndomethacinIndomethacinBlenheim Pharmacal, Inc.ANDACurrent
49999-371IndomethacinIndomethacinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
63629-3201IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-3201IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-3201IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
65162-506IndomethacinIndomethacinAmneal Pharmaceuticals LLCANDACurrent
66267-121IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-121IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
66336-687IndomethacinIndomethacinDispensing Solutions, Inc.ANDACurrent