FDA.reportPublic FDA data

Application 079175

Type
ANDA
Sponsor
AVANTHI INC

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
10702-016INDOMETHACINIndomethacinKVK-Tech, Inc.ANDACurrent
10702-016INDOMETHACINIndomethacinKVK-Tech, Inc.ANDACurrent
10702-016INDOMETHACINIndomethacinKVK-Tech, Inc.ANDACurrent
10702-016INDOMETHACINIndomethacinKVK-Tech, Inc.ANDACurrent
10702-016INDOMETHACINIndomethacinKVK-Tech, Inc.ANDACurrent
12634-160INDOMETHACIN ERINDOMETHACINApotheca, Inc.ANDACurrent
50090-0263INDOMETHACINIndomethacinA-S Medication SolutionsANDACurrent
55289-469INDOMETHACINIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-469INDOMETHACINIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-469INDOMETHACINIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-469INDOMETHACINIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-469INDOMETHACINIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-469INDOMETHACINIndomethacinPD-Rx Pharmaceuticals, InANDACurrent
68084-411IndomethacinIndomethacinAmerican Health PackagingANDACurrent
68084-411IndomethacinIndomethacinAmerican Health PackagingANDACurrent
68084-411IndomethacinIndomethacinAmerican Health PackagingANDACurrent
68151-1733INDOMETHACINIndomethacinCarilion Materials ManagementANDACurrent