FDA.reportPublic FDA data

Application 206488

Type
NDA
Sponsor
SAREPTA THERAPS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXONDYS 51ETEPLIRSENSOLUTION;INTRAVENOUS100MG/2ML (50MG/ML)YesYes
002EXONDYS 51ETEPLIRSENSOLUTION;INTRAVENOUS500MG/10ML (50MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60923-284Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-284Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-284Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-284Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-284Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-284Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-363Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-363Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-363Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-363Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-363Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent
60923-363Exondys 51eteplirsenSarepta Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80784SUPPL 2024-12-30
80782SUPPL 2024-12-30
69927SUPPL2022-01-19
69926SUPPL2022-01-19
69925SUPPL2022-01-19
69906SUPPL2022-01-19
69905SUPPL2022-01-19
69904SUPPL2022-01-19
63839SUPPL2020-07-09
63824SUPPL2020-07-08
55942SUPPL2018-10-15
55898SUPPL2018-10-12
54298SUPPL2018-05-22
52544SUPPL2018-02-09
52524SUPPL2018-02-09
45640ORIG2016-10-26
45367ORIG2016-09-19
45366ORIG2016-09-19
45365ORIG2016-09-19