FDA.reportPublic FDA data

Application 020333

Type
NDA
Sponsor
SHIRE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AGRYLINANAGRELIDE HYDROCHLORIDECAPSULE;ORALEQ 0.5MG BASENoNo
002AGRYLINANAGRELIDE HYDROCHLORIDECAPSULE;ORALEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54092-063Agrylinanagrelide hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
54092-063Agrylinanagrelide hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
54092-063Agrylinanagrelide hydrochlorideShire US Manufacturing Inc.NDACurrent
54092-063Agrylinanagrelide hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
54092-063Agrylinanagrelide hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
54092-063Agrylinanagrelide hydrochlorideShire US Manufacturing Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68993SUPPL2021-10-14
68987SUPPL2021-10-14
62018SUPPL2020-03-04
62011SUPPL2020-03-03
56949SUPPL2018-12-21
56899SUPPL2018-12-20
53490SUPPL2018-03-28
53252SUPPL2018-03-23
41284SUPPL2015-08-21
12462SUPPL2015-07-16
24795SUPPL2015-07-15
12461SUPPL2014-11-04
24794SUPPL2014-11-03
2348SUPPL2014-02-11
34517SUPPL2014-02-10
34516SUPPL2013-07-23
24793SUPPL2013-07-19
12460SUPPL2011-11-30
2347SUPPL2011-11-28
24792SUPPL2011-02-04
12459SUPPL2011-01-31
34515SUPPL2010-07-06
2346SUPPL2010-07-02
34514SUPPL2009-07-23
24791SUPPL2009-07-17
24790SUPPL2008-06-20
12458SUPPL2008-06-19
12457SUPPL2004-12-30
2345SUPPL2004-12-30
34513SUPPL2004-12-10
24789SUPPL2004-12-10
12456SUPPL2004-12-10
2344SUPPL2004-12-10
20598SUPPL1998-12-16
12455SUPPL1998-12-16
2343SUPPL1998-12-16
51770ORIG1900-01-01
51769ORIG1900-01-01
51768ORIG1900-01-01
51767ORIG1900-01-01
51766ORIG1900-01-01