FDA.reportPublic FDA data

Application 022572

Type
NDA
Sponsor
MOBIUS THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MITOSOLMITOMYCINFOR SOLUTION;TOPICAL0.2MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49771-002MitosolmitomycinMobius Therapeutics LLCNDACurrent
49771-002MitosolmitomycinMobius Therapeutics LLCNDACurrent
49771-002MitosolmitomycinMobius Therapeutics LLCNDACurrent
49771-002MitosolmitomycinMobius Therapeutics LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67261SUPPL2021-04-29
67182SUPPL2021-04-27
64253SUPPL2020-08-10
50932SUPPL2017-12-27
50911SUPPL2017-12-27
38856SUPPL2016-01-26
29873SUPPL2016-01-21
38855SUPPL2014-09-30
7556SUPPL2014-09-29
24344ORIG2013-01-02
22061ORIG2013-01-02
29872ORIG2012-02-14
17726ORIG2012-02-09