FDA.reportPublic FDA data

Application 017533

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KLONOPINCLONAZEPAMTABLET;ORAL0.5MGYesNo
002KLONOPINCLONAZEPAMTABLET;ORAL1MGYesYes
003KLONOPINCLONAZEPAMTABLET;ORAL2MGYesNo
005KLONOPINCLONAZEPAMTABLET;ORAL0.125MGNoNo
006KLONOPINCLONAZEPAMTABLET;ORAL0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0058KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0068KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0068KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0068KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0068KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0068KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0068KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0098KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0098KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0098KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0098KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0098KlonopinClonazepamGenentech, Inc.NDACurrent
0004-0098KlonopinClonazepamGenentech, Inc.NDACurrent
61269-605KlonopinClonazepamH2-Pharma, LLCNDACurrent
61269-605KlonopinClonazepamH2-Pharma, LLCNDACurrent
61269-610KlonopinClonazepamH2-Pharma, LLCNDACurrent
61269-610KlonopinClonazepamH2-Pharma, LLCNDACurrent
61269-620KlonopinClonazepamH2-Pharma, LLCNDACurrent
61269-620KlonopinClonazepamH2-Pharma, LLCNDACurrent
65084-308KlonopinClonazepamMckesson Rxpak IncNDACurrent
65084-309KlonopinClonazepamMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73201SUPPL2023-01-17
73200SUPPL2023-01-17
73167SUPPL2023-01-17
66147SUPPL2021-02-09
66146SUPPL2021-02-09
66126SUPPL2021-02-09
50222SUPPL2017-10-30
50188SUPPL2017-10-26
50187SUPPL2017-10-26
46460SUPPL2016-12-22
46281SUPPL2016-12-20
33297SUPPL2016-03-29
13836SUPPL2016-03-29
628SUPPL2013-11-06
11020SUPPL2013-11-01
33295SUPPL2012-06-04
626SUPPL2012-06-04
13835SUPPL2011-12-14
627SUPPL2010-09-21
33296SUPPL2010-09-07
11019SUPPL2009-05-12
625SUPPL2009-05-01
40747SUPPL2007-04-09
20077SUPPL2007-04-09
624SUPPL2002-01-29
623SUPPL2001-01-22