Application 090567

Type: ANDA
Sponsor: PADDOCK LLC

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/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090567-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-15

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 · 43 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	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090567-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-15	`f41ea6bd6efb…`

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 4 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Winco	POLYETHYLENE GLYCOL 3350	WINCO FOODS	d649f758-a46f-4864-8718-878ee5a74bfc	2025-04-10	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	NorthStar Rx LLC	2e7e72eb-b759-5b59-e063-6394a90aa7ff	2025-02-19	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
GAVILAX	POLYETHYLENE GLYCOL 3350	A-S Medication Solutions	581baa4b-7331-47a3-81c6-680286f03aca	2025-01-09	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
clear lax	POLYETHYLENE GLYCOL 3350	H E B	bd16827b-5e6a-4fa7-bc2e-c9a05e1e2dab	2024-12-02	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Leader ClearLax	POLYETHYLENE GLYCOL 3350	Cardinal Health 110, LLC. dba Leader	9b759bd9-3818-4b71-a99c-aa7e202bf22e	2024-10-01	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
rugby PEG 3350	POLYETHYLENE GLYCOL 3350	Bryant Ranch Prepack	fb3f889c-7f88-4850-9994-d436f9010990	2024-09-06	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Members Mark clearlax	POLYETHYLENE GLYCOL 3350	Sam's West Inc	5bc34a90-adc2-4031-b8a6-725829881550	2024-09-05	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
GENTLELAX	POLYETHYLENE GLYCOL 3350	Kroger Company	2390b507-93d5-43a0-aa51-31ca4edd6b7f	2024-07-03	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
careone clearlax	POLYETHYLENE GLYCOL 3350	Retail Business Services, LLC	2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd	2024-05-19	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	CHAIN DRUG MARKETING ASSOCIATION, INC.	901a1918-87bb-47c2-a465-8c468c3a1ee5	2024-03-26	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
smoothlax	POLYETHYLENE GLYCOL 3350	Walgreen Company	aeb5c32c-443e-4ea3-8e96-fed38225fdf3	2024-03-12	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Topcare ClearLax	POLYETHYLENE GLYCOL 3350	Topco Associates LLC	02f81a86-bec5-4e8b-bddb-d463ae2ea9e9	2024-02-07	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	Bryant Ranch Prepack	66276671-0ccd-4c32-a697-31e679fce0e3	2024-02-06	Warnings	Name fallback brand name: POLYETHYLENE GLYCOL 3350 generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	BluePoint Laboratories	02e36812-53c2-003b-e063-6394a90aed12	2024-01-31	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
Welby ClearLax	POLYETHYLENE GLYCOL 3350	Aldi, Inc	d64caba5-614f-4edc-bb47-ce4fed38ce45	2023-11-10	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
equaline clearlax	POLYETHYLENE GLYCOL 3350	United Natural Foods, Inc. dba UNFI	e0871542-9136-4cf8-a4b7-6c2b6edcbe0e	2023-08-07	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
good sense clearlax	POLYETHYLENE GLYCOL 3350	L. Perrigo Company	9858edef-cdb2-4ac4-8e4b-ba0720a24e41	2023-06-01	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
berkley and jensen clearlax	POLYETHYLENE GLYCOL 3350	BJWC	f9eb9023-c83b-49b4-af82-d8344ffa46c3	2023-05-12	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
dg health clearlax	POLYETHYLENE GLYCOL 3350	Dolgencorp Inc	ffae36fd-2fb7-4afb-a7f8-29c700a477fb	2023-05-04	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
clearlax	POLYETHYLENE GLYCOL 3350	Publix Super Markets Inc	ee30489a-8683-4403-8f85-76434242663c	2023-02-15	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350

Reported adverse events (FAERS/openFDA)#

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