Application 077893

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 42.

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
A077893-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077893-001	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	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077893-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2006-05-26	`e64feba35796…`

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
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
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	7ed915ec-7e99-4e0e-aca0-20718987a88c	2026-08-07	Warnings	Name fallback 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
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Strides Pharma Inc	77b9060f-c9ab-4047-b1f1-063956678453	2026-07-15	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic 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
GAVILAX	POLYETHYLENE GLYCOL 3350	Atlantic Biologicals Corp.	4c207478-6f0f-c3cf-e063-6394a90aa4f2	2026-06-04	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	Major Pharmaceuticals	ddc9d2b1-87d8-44fa-bac6-0a7261f33564	2026-05-12	Warnings	Name fallback brand name: Polyethylene glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
smooth lax	POLYETHYLENE GLYCOL 3350	Walgreen Company	3027af65-2f7f-472d-83f5-254d5d75013c	2026-05-08	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
MiraLAX	POLYETHYLENE GLYCOL 3350	Bayer HealthCare LLC.	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	2026-05-04	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
GAVILAX	POLYETHYLENE GLYCOL 3350	Preferred Pharmaceuticals, Inc.	21654def-5ae0-422d-961b-1fe2456af00a	2026-05-04	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	CARDINAL HEALTH 110, LLC. DBA LEADER	04cc4f2e-1725-4710-8cfb-73a6bdf52e4f	2026-04-23	Warnings	Name fallback brand name: POLYETHYLENE GLYCOL 3350 generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Aurobindo Pharma Limited	b51f2223-8266-4d6c-bf32-58e53e73b54d	2026-04-23	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
COMFORTLAX	POLYETHYLENE GLYCOL 3350	Family Dollar Stores, LLC	02a44a41-0039-f6ec-e063-6394a90ae6f1	2026-04-23	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Aurohealth LLC	d3c77f3f-57aa-4e2d-88aa-731cbb22af70	2026-04-23	Warnings	Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350
clear lax	POLYETHYLENE GLYCOL 3350	Meijer Distribution Inc	6464f12c-0883-46c5-943b-a84fe235588e	2026-04-13	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0412	Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Paddock Laboratories, LLC	ANDA	Current
55154-6707	Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health	ANDA	Current
55154-6707	Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health	ANDA	Current
63187-030	Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	ANDA	Current
63187-030	Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	ANDA	Current