FDA.reportPublic FDA data

Application 208073

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XIIDRALIFITEGRASTSOLUTION/DROPS;OPHTHALMIC5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0911XiidraLifitegrastNovartis Pharmaceuticals CorporationNDACurrent
0078-0911XiidraLifitegrastNovartis Pharmaceuticals CorporationNDACurrent
0078-0911XiidraLifitegrastNovartis Pharmaceuticals CorporationNDACurrent
0078-0911XiidraLifitegrastNovartis Pharmaceuticals CorporationNDACurrent
54092-606XiidraLifitegrastTakeda Pharmaceuticals America, Inc.NDACurrent
54092-606XiidraLifitegrastShire US Manufacturing Inc.NDACurrent
54092-606XiidraLifitegrastShire US Manufacturing Inc.NDACurrent
54092-606XiidraLifitegrastShire US Manufacturing Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78500SUPPL 2024-05-20
78499SUPPL 2024-05-20
63430SUPPL2020-06-08
63427SUPPL2020-06-05
50826SUPPL2017-12-21
50786SUPPL2017-12-20
19982ORIG2016-07-13
10642ORIG2016-07-12
45000ORIG2016-07-11