Application 209017

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	FOR SOLUTION;ORAL	17GM/PACKET	No	No

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
A209017-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2018-04-09
A209017-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2024-04-23

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209017-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2024-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209017-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2024-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209017-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2024-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
365 WHOLE FOODS MARKET Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Whole Foods Market, Inc.	b19f42a9-18ac-4d23-87b5-3c43e47c4054	2026-06-05	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	CARDINAL HEALTH 110, LLC. DBA LEADER	04cc4f2e-1725-4710-8cfb-73a6bdf52e4f	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Aurobindo Pharma Limited	b51f2223-8266-4d6c-bf32-58e53e73b54d	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
COMFORTLAX	POLYETHYLENE GLYCOL 3350	Family Dollar Stores, LLC	02a44a41-0039-f6ec-e063-6394a90ae6f1	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Aurohealth LLC	d3c77f3f-57aa-4e2d-88aa-731cbb22af70	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017 ndc (product): 58602-805

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58602-805	Polyethylene Glycol 3350	Polyethylene Glycol 3350	Aurohealth LLC	ANDA	Current
58602-805	Polyethylene Glycol 3350	Polyethylene Glycol 3350	Aurohealth LLC	ANDA	Current
58602-805	Polyethylene Glycol 3350	Polyethylene Glycol 3350	Aurohealth LLC	ANDA	Current
58602-805	Polyethylene Glycol 3350	Polyethylene Glycol 3350	Aurohealth LLC	ANDA	Current