FDA.reportPublic FDA data

Application 204300

Type
NDA
Sponsor
AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VAZCULEPPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)YesYes
002VAZCULEPPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)YesYes
003VAZCULEPPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-4000VazculepPhenylephrine HydrochlorideExela Phrama Sciences, LLCNDACurrent
51754-4010VazculepPhenylephrine HydrochlorideExela Phrama Sciences, LLCNDACurrent
51754-4020VazculepPhenylephrine HydrochlorideExela Phrama Sciences, LLCNDACurrent
68001-331VazculepPhenylephrine HydrochlorideBluePoint LaboratoriesNDACurrent
71872-7042VazculepPhenylephrine HydrochlorideMedical Purchasing Solutions, LLCNDACurrent
71872-7042VazculepPhenylephrine HydrochlorideMedical Purchasing Solutions, LLCNDACurrent
76014-004VazculepPhenylephrine HydrochlorideAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-004VazculepPhenylephrine HydrochlorideAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-004VazculepPhenylephrine HydrochlorideAvadel Legacy Pharmaceuticals, LLCNDACurrent
76014-004VazculepPhenylephrine HydrochlorideAvadel Legacy Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62584SUPPL2020-04-17
62281SUPPL2020-03-24
60619SUPPL2019-10-22
60611SUPPL2019-10-21
32541SUPPL2015-05-29
44898ORIG2015-05-14
43461ORIG2015-05-14
40372ORIG2014-06-30
32540ORIG2014-06-30