FDA.reportPublic FDA data

Application 074464

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE, EXTENDED RELEASE;ORAL75MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0720IndomethacinIndomethacinEon Labs, Inc.ANDACurrent
0185-0720IndomethacinIndomethacinEon Labs, Inc.ANDACurrent
12634-838INDOMETHACIN ERINDOMETHACINApotheca, Inc.ANDACurrent
68387-345Indomethacin extended-releaseIndomethacin extended-releaseKeltman Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22337ORIG1998-05-28
8415ORIG1998-05-28