FDA.reportPublic FDA data

Application 208684

Type
NDA
Sponsor
PTC THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMFLAZADEFLAZACORTTABLET;ORAL6MGYesNo
002EMFLAZADEFLAZACORTTABLET;ORAL18MGYesNo
003EMFLAZADEFLAZACORTTABLET;ORAL30MGYesNo
004EMFLAZADEFLAZACORTTABLET;ORAL36MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42998-501EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-501EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-502EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-502EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-503EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-503EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-504EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
42998-504EMFLAZAdeflazacortMarathon Pharmaceuticals, LLCNDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-501EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-502EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-503EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent
52856-504EMFLAZAdeflazacortPTC Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78739SUPPL 2024-07-02
78663SUPPL 2024-06-06
70085SUPPL2022-02-04
67978SUPPL2021-06-30
63950SUPPL2020-07-17
63890SUPPL2020-07-14
59009SUPPL2019-06-11
58996SUPPL2019-06-07
47511ORIG2017-03-09
47143ORIG2017-02-09
47140ORIG2017-02-09