FDA.reportPublic FDA data

Application 211280

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REYVOWLASMIDITAN SUCCINATETABLET;ORAL50MGYesNo
002REYVOWLASMIDITAN SUCCINATETABLET;ORAL100MGYesYes
003REYVOWLASMIDITAN SUCCINATETABLET;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72244SUPPL2022-10-05
72243SUPPL2022-10-05
72093SUPPL2022-09-16
71595SUPPL2022-07-19
71594SUPPL2022-07-19
71578SUPPL2022-07-18
69993SUPPL2022-01-28
68932ORIG2021-10-08
67713SUPPL2021-06-07
67710SUPPL2021-06-04
67709SUPPL2021-06-04
64066SUPPL2020-07-23
64065SUPPL2020-07-23
63975SUPPL2020-07-20
63378ORIG2020-06-02
61911ORIG2020-02-19
61908ORIG2020-02-19