FDA.reportPublic FDA data

Application 203202

Type
NDA
Sponsor
LUNDBECK NA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORTHERADROXIDOPACAPSULE;ORAL100MGYesNo
002NORTHERADROXIDOPACAPSULE;ORAL200MGYesNo
003NORTHERADROXIDOPACAPSULE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67386-820NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-820NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-820NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-820NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-820NortheradroxidopaLundbeck Pharmaceuticals NDACurrent
67386-820NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-821NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-821NortheradroxidopaLundbeck Pharmaceuticals NDACurrent
67386-821NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-821NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-821NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-821NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-822NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-822NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-822NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-822NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-822NortheradroxidopaLundbeck Pharmaceuticals LLCNDACurrent
67386-822NortheradroxidopaLundbeck Pharmaceuticals NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47177SUPPL2017-02-13
47175SUPPL2017-02-13
45493SUPPL2016-10-06
45477SUPPL2016-10-05
22915ORIG2014-03-20
40274ORIG2014-02-19
10183ORIG2014-02-19