FDA.reportPublic FDA data

Application 204078

Type
NDA
Sponsor
AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLOXIVERZNEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS5MG/10ML (0.5MG/ML)YesYes
002BLOXIVERZNEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS10MG/10ML (1MG/ML)YesYes
003BLOXIVERZNEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS5MG/5ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-1210BloxiverzNeostigmine MethylsulfateExela Pharma Sciences, LLCNDACurrent
51754-1210BloxiverzNeostigmine MethylsulfateExela Pharma Sciences, LLCNDACurrent
51754-1220BloxiverzNeostigmine MethylsulfateExela Pharma Sciences, LLCNDACurrent
51754-1220BloxiverzNeostigmine MethylsulfateExela Pharma Sciences, LLCNDACurrent
51754-1240Bloxiverzneostigmine methylsulfateExela Pharma Sciences, LLCNDACurrent
51754-1240Bloxiverzneostigmine methylsulfateExela Pharma Sciences, LLCNDACurrent
68001-329BloxiverzNeostigmine MethylsulfateBluePoint LaboratoriesNDACurrent
76014-002BloxiverzNeostigmine MethylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-002BloxiverzNeostigmine MethylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-003BloxiverzNeostigmine MethylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-003BloxiverzNeostigmine MethylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-902Bloxiverzneostigmine methylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-903Bloxiverzneostigmine methylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-903Bloxiverzneostigmine methylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-903Bloxiverzneostigmine methylsulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76871SUPPL 2023-12-15
76856SUPPL 2023-12-15
65955SUPPL2021-01-22
65947SUPPL2021-01-21
19524SUPPL2015-10-22
32503SUPPL2015-10-21
40352SUPPL2014-12-16
10293SUPPL2014-12-12
44894ORIG2014-05-27
43455ORIG2014-05-27
32502ORIG2013-06-04
19523ORIG2013-06-04
51400ORIG1900-01-01
51399ORIG1900-01-01