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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022015-001MIRALAXPOLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06
N022015-002MIRALAXPOLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-05-13 08:27 UTC2023-05N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022015-002MIRALAX17GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-06a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
ndc (product): 30142-526
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
application applno (NDA): 022015
application number: NDA022015
ndc (product): 11523-4357
ndc (product): 11523-7341
ndc (product): 11523-7268
ndc (product): 11523-7234
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsExact identifier
application applno (NDA): 022015
application number: NDA022015
ndc (product): 55154-5035
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsExact identifier
application applno (NDA): 022015
application number: NDA022015

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

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