Application 077736

Type: ANDA
Sponsor: BRECKENRIDGE PHARM

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
A077736-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2006-05-26

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	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077736-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`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 1 of 5 · 97 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	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	L.N.K. International, Inc.	bbc11078-73f7-4d27-b0d3-4d4ae5dae240	2026-09-10	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	7ed915ec-7e99-4e0e-aca0-20718987a88c	2026-09-08	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	fc3b6006-a75a-41b3-9f0b-a3152df1363f	2026-09-04	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
basic care clearlax	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	1ccb8604-34f6-4e1e-beed-eb81d6aa7aef	2026-09-03	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	006a9eca-400f-47f5-bee5-facf7034043e	2026-09-02	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Kroger	POLYETHYLENE GLYCOL 3350	KROGER COMPANY	c56271ff-703a-40c4-840f-1962798c9e42	2026-09-02	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
gentle lax	POLYETHYLENE GLYCOL 3350	Kroger Company	0d820dcc-440a-4036-86e9-fdb30cac9573	2026-09-01	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	bd33463b-eb1a-41ed-92d1-f50d0923eb3b	2026-08-31	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	4d524ace-9de5-4f62-9263-7cd88a36b67c	2026-08-28	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
PEG3350	POLYETHYLENE GLYCOL 3350	Major Pharmaceuticals	161629f6-6193-4712-bba7-7d5b174a9338	2026-08-28	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Mix-In Laxative Packets	POLYETHYLENE GLYCOL 3350	Wal-Mart Stores Inc	0347c934-1e85-4f8d-8d35-bb07f16810ad	2026-08-27	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Preferred Pharmaceuticals Inc.	cccbe459-813d-4668-8cd2-76be82906a32	2026-08-17	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	The Fresh Test, LLC	cb8e182f-c23f-4f8d-9c09-24e19b2e914e	2026-08-05	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	INSTALAX POLYETHYLENE GLYCOL 3350	Sun Pharmaceutical Industries, Inc.	40bd1be7-de67-8dff-e063-6294a90aca95	2026-07-24	Warnings	Name fallback brand name: Polyethylene Glycol 3350
clear lax	POLYETHYLENE GLYCOL 3350	HyVee Inc	5bcf01d8-ddf3-4e64-8d3f-3526a51a5859	2026-07-02	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
CLEARLAX	POLYETHYLENE GLYCOL 3350	Safeway	a70f41d0-0fad-4d15-8844-d60eabeb6732	2026-07-02	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	4e8b6a32-11ec-4419-9ec8-aaa182389972	2026-06-19	Warnings	Name fallback brand name: Polyethylene glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	PIONEER LIFE SCIENCES, LLC	478f104a-0e50-479c-8722-a3f1eab68691	2026-06-11	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
365 WHOLE FOODS MARKET Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Whole Foods Market, Inc.	b19f42a9-18ac-4d23-87b5-3c43e47c4054	2026-06-05	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350

Reported adverse events (FAERS/openFDA)#

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