FDA.reportPublic FDA data

Application 208289

Type
NDA
Sponsor
AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AKOVAZEPHEDRINE SULFATESOLUTION;INTRAVENOUS50MG/ML (50MG/ML)YesYes
002AKOVAZEPHEDRINE SULFATESOLUTION;INTRAVENOUS25MG/5ML (5MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-4200Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
51754-4200Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
51754-4200Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
51754-4200Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
51754-4250Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
51754-4250Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
51754-4250Akovazephedrine sulfateExela Pharma Sciences, LLCNDACurrent
68001-330Akovazephedrine sulfateBluePoint LaboratoriesNDACurrent
68001-330Akovazephedrine sulfateBluePoint LaboratoriesNDACurrent
76014-005Akovazephedrine sulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-005Akovazephedrine sulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-005Akovazephedrine sulfateAvadel Legacy Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71466SUPPL2022-06-28
68624SUPPL2021-09-15
68293SUPPL2021-08-04
62537SUPPL2020-04-10
62523SUPPL2020-04-09
55227SUPPL2018-08-20
55166SUPPL2018-08-13
44974ORIG2016-05-24
23054ORIG2016-05-24
19990ORIG2016-05-05
10653ORIG2016-05-04