Application 022015

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRALAX	POLYETHYLENE GLYCOL 3350	FOR SOLUTION;ORAL	17GM/SCOOPFUL	Yes	Yes
002	MIRALAX	POLYETHYLENE GLYCOL 3350	FOR SOLUTION;ORAL	17GM/PACKET	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022015-001	MIRALAX	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL		RLD, RS	2006-10-06
N022015-002	MIRALAX	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL		RLD, RS	2006-10-06

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 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3bdfa0b2c4d7…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MiraLAX	POLYETHYLENE GLYCOL 3350	Bayer HealthCare LLC.	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	2026-05-04	Warnings	Exact identifier application applno (NDA): 022015 application number: NDA022015 ndc (product): 11523-4357 ndc (product): 11523-7341 ndc (product): 11523-7268 ndc (product): 11523-7234
MiraLAX	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	1771d3bf-954d-49ea-b260-3d356e5dcfa5	2025-11-07	Warnings	Exact identifier application applno (NDA): 022015 application number: NDA022015 ndc (product): 55154-5035
MiraLAX	POLYETHYLENE GLYCOL 3350	ASCLEMED USA INC.	e652042f-3707-4bf6-831d-d806638b7d85	2025-10-14	Warnings	Exact identifier application applno (NDA): 022015 application number: NDA022015
Kroger	POLYETHYLENE GLYCOL 3350	KROGER COMPANY	c56271ff-703a-40c4-840f-1962798c9e42	2025-08-04	Warnings	Exact identifier ndc (product): 30142-526

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11523-4357	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-4357	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-4357	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-4357	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-4357	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7234	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7234	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7234	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7234	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7234	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7268	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7268	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7268	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7268	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7268	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7341	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7341	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7341	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7341	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
11523-7341	MiraLAX	Polyethylene Glycol 3350	Bayer HealthCare LLC.	NDA	Current
30142-526	Kroger	Polyethylene Glycol 3350	KROGER COMPANY	NDA	Current
55154-5035	MiraLAX	Polyethylene Glycol 3350	Cardinal Health 107, LLC	NDA	Current
55154-5035	MiraLAX	Polyethylene Glycol 3350	Cardinal Health	NDA	Current
55154-5035	MiraLAX	Polyethylene Glycol 3350	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83609	SUPPL	2025-09-30
81175	SUPPL	2025-02-07
76015	SUPPL	2023-10-31
75514	SUPPL	2023-09-19
74943	SUPPL	2023-07-31
74916	SUPPL	2023-07-28
74569	SUPPL	2023-06-21
74568	SUPPL	2023-06-21
73853	SUPPL	2023-03-24
73852	SUPPL	2023-03-24
71521	SUPPL	2022-07-06
71723	SUPPL	2022-07-05
67488	SUPPL	2021-05-14
67195	SUPPL	2021-04-28
58981	SUPPL	2019-06-05
58980	SUPPL	2019-06-05
55961	SUPPL	2018-10-17
55931	SUPPL	2018-10-15
55331	SUPPL	2018-08-27
55220	SUPPL	2018-08-20
54053	SUPPL	2018-05-08
54045	SUPPL	2018-05-08
54005	SUPPL	2018-05-03
53864	SUPPL	2018-04-27
50096	SUPPL	2017-10-18
49973	SUPPL	2017-10-06
45643	SUPPL	2016-10-27
45637	SUPPL	2016-10-25
45586	SUPPL	2016-10-11
45476	SUPPL	2016-10-05
16774	SUPPL	2015-11-19
6692	SUPPL	2015-11-16
29086	SUPPL	2015-11-04
16773	SUPPL	2015-11-04
29085	SUPPL	2014-08-06
38088	SUPPL	2014-08-04
6691	SUPPL	2012-03-19
6690	SUPPL	2010-05-07
6689	SUPPL	2008-12-04
29084	SUPPL	2008-11-21
21908	ORIG	2007-06-22
29083	ORIG	2006-10-13