Application 090685

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	FOR SOLUTION;ORAL	17GM/PACKET	No	No
002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	FOR SOLUTION;ORAL	17GM/SCOOPFUL	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090685-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2009-10-06
A090685-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-06

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`74a2ff9319b5…`

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 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leader clearlax	POLYETHYLENE GLYCOL 3350	Cardinal Health 110, LLC. dba Leader	812c59b0-e7ce-4c7a-91ed-e74b7b1b84be	2026-09-22	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685 ndc (product): 70000-0415
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	7ed915ec-7e99-4e0e-aca0-20718987a88c	2026-09-08	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	fc3b6006-a75a-41b3-9f0b-a3152df1363f	2026-09-04	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
basic care clearlax	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	1ccb8604-34f6-4e1e-beed-eb81d6aa7aef	2026-09-03	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685 ndc (product): 72288-499
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	006a9eca-400f-47f5-bee5-facf7034043e	2026-09-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
gentle lax	POLYETHYLENE GLYCOL 3350	Kroger Company	0d820dcc-440a-4036-86e9-fdb30cac9573	2026-09-01	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	bd33463b-eb1a-41ed-92d1-f50d0923eb3b	2026-08-31	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
clear lax	POLYETHYLENE GLYCOL 3350	HyVee Inc	5bcf01d8-ddf3-4e64-8d3f-3526a51a5859	2026-07-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
CLEARLAX	POLYETHYLENE GLYCOL 3350	Safeway	a70f41d0-0fad-4d15-8844-d60eabeb6732	2026-07-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
smooth lax	POLYETHYLENE GLYCOL 3350	Walgreen Company	3027af65-2f7f-472d-83f5-254d5d75013c	2026-05-08	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
clear lax	POLYETHYLENE GLYCOL 3350	Meijer Distribution Inc	6464f12c-0883-46c5-943b-a84fe235588e	2026-04-13	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
equate clear lax	POLYETHYLENE GLYCOL 3350	Wal-Mart Stores Inc	56a507f3-0cd1-4f02-9dfd-de297ba4bc1f	2026-03-27	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
foster and thrive clearlax	POLYETHYLENE GLYCOL 3350	Strategic Sourcing Services LLC	684e35cc-5a4f-458d-b5e7-e1933fea1139	2026-03-07	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Topcare ClearLax	POLYETHYLENE GLYCOL 3350	Topco Associates LLC	03291fd3-7b64-4b79-ad84-e1b9b30a6b03	2026-02-19	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Good Sense Clear Lax	POLYETHYLENE GLYCOL 3350	Preferred Pharmaceuticals Inc.	935f05da-3637-4a9e-843e-1f2ced5d1a74	2026-01-23	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
MiraLAX Orange Flavor	POLYETHYLENE GLYCOL 3350	Bayer HealthCare LLC.	0a5b2121-928f-8f49-e063-6394a90a8aaf	2025-12-04	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	A-S Medication Solutions	4f31a33e-1f60-4aa7-b1dc-a3c011c03a70	2025-10-29	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Laxative	POLYETHYLENE GLYCOL 3350	Rite Aid Corporation	457f5d2d-4595-482a-9ffa-659fb5d5b134	2025-10-09	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Bryant Ranch Prepack	5df518fb-ad58-4f17-af34-f66066f1313a	2025-09-30	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Dulcolax	POLYETHYLENE GLYCOL 3350	Chattem, Inc.	ed16d0f4-74e7-4fa3-989d-c6840a5d3e71	2025-09-30	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685

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 3 of 3 · 175 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70000-0415	leader clearlax	Polyethylene Glycol 3350	Cardinal Health	ANDA	Current
70000-0415	leader clearlax	Polyethylene Glycol 3350	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0415	leader clearlax	Polyethylene Glycol 3350	Cardinal Health	ANDA	Current
70925-306	Humana Pharmacy Clear Laxative	Polyethylene Glycol 3350	Humana Pharmacy, Inc.	ANDA	Current
70925-306	Humana Pharmacy Clear Laxative	Polyethylene Glycol 3350	Humana Pharmacy, Inc.	ANDA	Current
70925-306	Humana Pharmacy Clear Laxative	Polyethylene Glycol 3350	Humana Pharmacy, Inc.	ANDA	Current
71205-447	Good Sense Clear Lax	Polyethylene Glycol 3350	Proficient Rx LP	ANDA	Current
71205-447	Good Sense Clear Lax	Polyethylene Glycol 3350	Proficient Rx LP	ANDA	Current
71205-447	Good Sense Clear Lax	Polyethylene Glycol 3350	Proficient Rx LP	ANDA	Current
72288-020	basic care clearlax	Polyethylene Glycol 3350	Amazon.com Services LLC	ANDA	Current
72288-499	basic care clearlax	Polyethylene Glycol 3350	Amazon.com Services LLC	ANDA	Current
72288-499	basic care clearlax	Polyethylene Glycol 3350	Amazon.com Services LLC	ANDA	Current
72288-499	basic care clearlax	Polyethylene Glycol 3350	Amazon.com Services Inc.	ANDA	Current
72288-499	basic care clearlax	Polyethylene Glycol 3350	Amazon.com Services LLC	ANDA	Current
79903-114	Equate ClearLAX	Polyethylene Glycol 3350	WALMART INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31486	ORIG	2009-10-14