FDA.reportPublic FDA data

Application 208685

Type
NDA
Sponsor
PTC THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMFLAZADEFLAZACORTSUSPENSION;ORAL22.75MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42998-505EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-505EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-505EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78740SUPPL 2024-07-02
78664SUPPL 2024-06-06
70086SUPPL2022-02-04
67979SUPPL2021-06-30
63951SUPPL2020-07-17
63891SUPPL2020-07-14
59010SUPPL2019-06-11
58989SUPPL2019-06-07
47142ORIG2017-02-09
47141ORIG2017-02-09