FDA.reportPublic FDA data

Application 018851

Type
NDA
Sponsor
HERITAGE

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
23155-010IndomethacinIndomethacinHeritage Pharmaceuticals Inc.NDACurrent
23155-011IndomethacinIndomethacinHeritage Pharmaceuticals Inc.NDACurrent
42254-237INDOMETHACINindomethacinRebel Distributors CorpANDACurrent
43063-594IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-594IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.NDACurrent
55700-378IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-487INDOMETHACININDOMETHACINDirectRXNDACurrent
61919-985INDOMETHACININDOMETHACINDIRECT RXNDACurrent
61919-985INDOMETHACININDOMETHACINDIRECT RXNDACurrent
63187-290INDOMETHACINindomethacinProficient Rx LPNDACurrent
63187-697INDOMETHACINindomethacinProficient Rx LPNDACurrent
63629-1418IndomethacinIndomethacinBryant Ranch PrepackNDACurrent
63629-1418IndomethacinIndomethacinBryant Ranch PrepackNDACurrent
63629-1418IndomethacinIndomethacinBryant Ranch PrepackNDACurrent
63629-1780IndomethacinIndomethacinBryant Ranch PrepackNDACurrent
63629-1780IndomethacinIndomethacinBryant Ranch PrepackNDACurrent
67296-0560IndomethacinIndomethacinRedPharm Drug Inc.ANDACurrent
67296-1008IndomethacinIndomethacinRedPharm Drug, Inc.NDACurrent
67296-1008IndomethacinIndomethacinRedPharm Drug, Inc.NDACurrent
67296-1107IndomethacinIndomethacinRedPharm Drug, Inc.NDACurrent
67296-1107IndomethacinIndomethacinRedPharm Drug, Inc.NDACurrent
68151-2919IndomethacinIndomethacinCarilion Materials ManagementNDACurrent
68788-9107INDOMETHACINindomethacinPreferred Pharmaceuticals, Inc.NDACurrent
68788-9108INDOMETHACINindomethacinPreferred Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80377SUPPL 2024-11-25
80376SUPPL 2024-11-25
80279SUPPL 2024-11-22
67308SUPPL2021-04-30
67306SUPPL2021-04-30
67260SUPPL2021-04-29
1107SUPPL2016-05-12
11352SUPPL2016-05-11