FDA.reportPublic FDA data

Application 022015

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRALAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULYesYes
002MIRALAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
30142-526KrogerPolyethylene Glycol 3350KROGER COMPANYNDACurrent
55154-5035MiraLAXPolyethylene Glycol 3350Cardinal Health 107, LLCNDACurrent
55154-5035MiraLAXPolyethylene Glycol 3350Cardinal HealthNDACurrent
55154-5035MiraLAXPolyethylene Glycol 3350Cardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83609SUPPL 2025-09-30
81175SUPPL 2025-02-07
76015SUPPL 2023-10-31
75514SUPPL 2023-09-19
74943SUPPL 2023-07-31
74916SUPPL 2023-07-28
74569SUPPL 2023-06-21
74568SUPPL 2023-06-21
73853SUPPL 2023-03-24
73852SUPPL 2023-03-24
71521SUPPL2022-07-06
71723SUPPL2022-07-05
67488SUPPL2021-05-14
67195SUPPL2021-04-28
58981SUPPL2019-06-05
58980SUPPL2019-06-05
55961SUPPL2018-10-17
55931SUPPL2018-10-15
55331SUPPL2018-08-27
55220SUPPL2018-08-20
54053SUPPL2018-05-08
54045SUPPL2018-05-08
54005SUPPL2018-05-03
53864SUPPL2018-04-27
50096SUPPL2017-10-18
49973SUPPL2017-10-06
45643SUPPL2016-10-27
45637SUPPL2016-10-25
45586SUPPL2016-10-11
45476SUPPL2016-10-05
16774SUPPL2015-11-19
6692SUPPL2015-11-16
29086SUPPL2015-11-04
16773SUPPL2015-11-04
29085SUPPL2014-08-06
38088SUPPL2014-08-04
6691SUPPL2012-03-19
6690SUPPL2010-05-07
6689SUPPL2008-12-04
29084SUPPL2008-11-21
21908ORIG2007-06-22
29083ORIG2006-10-13