FDA.reportPublic FDA data

Application 021903

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOPROFENIBUPROFEN LYSINEINJECTABLE;INTRAVENOUSEQ 20MG BASE/2ML (EQ 10MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55292-122NeoProfenibuprofen lysineRECORDATI RARE DISEASES, INC.NDACurrent
55292-122NEOPROFENibuprofen lysineRecordati Rare Diseases Inc.NDACurrent
55292-122NEOPROFENibuprofen lysineRecordati Rare Diseases Inc.NDACurrent
55292-122NeoProfenibuprofen lysineRECORDATI RARE DISEASES INC.NDACurrent
55292-122NeoProfenibuprofen lysineRECORDATI RARE DISEASES, INC.NDACurrent
55292-122NeoProfenibuprofen lysineRECORDATI RARE DISEASES INC.NDACurrent
66993-490Ibuprofen Lysineibuprofen lysinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-490Ibuprofen Lysineibuprofen lysinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-490Ibuprofen Lysineibuprofen lysinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75972SUPPL 2023-10-27
66914SUPPL2021-03-30
66900SUPPL2021-03-29
59706SUPPL2019-08-15
50092SUPPL2017-10-18
50068SUPPL2017-10-17
16544SUPPL2016-01-26
6420SUPPL2016-01-15
6419SUPPL2013-12-05
37847SUPPL2013-12-04
16543SUPPL2010-01-04
6418SUPPL2009-12-31
6417SUPPL2008-09-16
21864ORIG2008-04-22
37846ORIG2006-04-14