FDA.reportPublic FDA data

Application 021232

Type
NDA
Sponsor
SWEDISH ORPHAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORFADINNITISINONECAPSULE;ORAL2MGYesNo
002ORFADINNITISINONECAPSULE;ORAL5MGYesNo
003ORFADINNITISINONECAPSULE;ORAL10MGYesNo
004ORFADINNITISINONECAPSULE;ORAL20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66658-102OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-102OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-102OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-105OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-105OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-105OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-110OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-110OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-110OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-120OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-120OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent
66658-120OrfadinNitisinoneSWEDISH ORPHAN BIOVITRUM AB (PUBL)NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58789SUPPL2019-05-20
58783SUPPL2019-05-20
49670SUPPL2017-09-06
49661SUPPL2017-09-05
48924SUPPL2017-07-07
36424SUPPL2016-06-17
14693SUPPL2014-05-28
27155SUPPL2014-05-22
4720SUPPL2013-02-15
14692SUPPL2013-02-14
4719SUPPL2010-02-05
36423SUPPL2010-02-04
27154ORIG2002-01-18
21530ORIG2002-01-18
14691ORIG2002-01-18