FDA.reportPublic FDA data

Application 021782

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROZEREMRAMELTEONTABLET;ORAL8MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-183RozeremramelteonRebel Distributors CorpNDACurrent
63629-3389RozeremramelteonBryant Ranch PrepackNDACurrent
63629-3389RozeremramelteonBryant Ranch PrepackNDACurrent
64764-805RozeremramelteonTakeda Pharmaceuticals America, Inc.NDACurrent
64764-805RozeremramelteonTakeda Pharmaceuticals America, Inc.NDACurrent
64764-805RozeremramelteonTakeda Pharmaceuticals America, Inc.NDACurrent
64764-805RozeremramelteonTakeda Pharmaceuticals America, Inc.NDACurrent
68151-4881RozeremramelteonCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69239SUPPL2021-11-05
69238SUPPL2021-11-05
69234SUPPL2021-11-05
57068SUPPL2018-12-30
57021SUPPL2018-12-26
57020SUPPL2018-12-26
28594SUPPL2012-03-05
6181SUPPL2012-03-05
6178SUPPL2012-03-05
28595SUPPL2011-08-05
28593SUPPL2010-11-15
37645SUPPL2010-11-12
23298SUPPL2010-11-12
37644SUPPL2008-11-07
16362SUPPL2008-11-07
16361SUPPL2008-11-07
28592SUPPL2008-10-23
6180SUPPL2008-10-23
6179SUPPL2008-10-23
42308ORIG2005-10-20
23676ORIG2005-08-30
37643SUPPL2005-08-23
28591SUPPL2005-08-23
37642ORIG2005-07-26
6177ORIG2005-07-26