FDA.reportPublic FDA data

Application 013263

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002VALIUMDIAZEPAMTABLET;ORAL2MGYesNo
004VALIUMDIAZEPAMTABLET;ORAL5MGYesNo
006VALIUMDIAZEPAMTABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0140-0004ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0004ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0004ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0004ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0004ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0005ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0005ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0005ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0005ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0005ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0006ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0006ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0006ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0006ValiumdiazepamRoche Laboratories Inc.NDACurrent
0140-0006ValiumdiazepamRoche Laboratories Inc.NDACurrent
55289-117ValiumdiazepamPD-Rx Pharmaceuticals, Inc.NDACurrent
65084-312ValiumdiazepamMckesson Rxpak IncNDACurrent
65084-313ValiumdiazepamMckesson Rxpak IncNDACurrent
80725-004ValiumDiazepamWaylis Therapuetics LLCNDACurrent
80725-004ValiumDiazepamWaylis Therapuetics LLCNDACurrent
80725-005ValiumDiazepamWaylis Therapuetics LLCNDACurrent
80725-005ValiumDiazepamWaylis Therapuetics LLCNDACurrent
80725-006ValiumDiazepamWaylis Therapuetics LLCNDACurrent
80725-006ValiumDiazepamWaylis Therapuetics LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78398SUPPL 2024-05-06
78395SUPPL 2024-05-06
75719SUPPL 2023-10-13
75718SUPPL 2023-10-13
75717SUPPL 2023-10-12
75716SUPPL 2023-10-12
73783SUPPL 2023-03-17
73782SUPPL 2023-03-17
73236SUPPL2023-01-17
73235SUPPL2023-01-17
73164SUPPL2023-01-17
66203SUPPL2021-02-12
66137SUPPL2021-02-09
46584SUPPL2016-12-29
46457SUPPL2016-12-22
46318SUPPL2016-12-20
33104SUPPL2013-10-25
12049SUPPL2013-10-24
10832SUPPL2008-06-05
12047SUPPL2008-05-14
358SUPPL2008-05-14
40690SUPPL2007-07-09
40688SUPPL2007-07-06
40687SUPPL2007-07-06
20044SUPPL2007-07-06
40689SUPPL2006-10-25
357SUPPL2004-06-29
359SUPPL2002-02-12
12046SUPPL2002-02-07
12048SUPPL2001-05-09