Application 206105

Type: ANDA
Sponsor: NUVO PHARMS INC

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 1.

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
A206105-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2016-10-28

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206105-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-10-28	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POLYETHYLENE GLYCOL 3350 NF	POLYETHYLENE GLYCOL 3350	SUNRISE PHARMACEUTICAL, INC	ce5197a1-2677-4ffb-aef2-9221b28ebd23	2020-01-22	Warnings	Exact identifier application applno (ANDA): 206105 application number: ANDA206105 ndc (product): 11534-180

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11534-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	SUNRISE PHARMACEUTICAL, INC	ANDA	Current
11534-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	SUNRISE PHARMACEUTICAL, INC	ANDA	Current
42576-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	NUVO PHARMACEUTICAL INC.	ANDA	Current
69784-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	Woodward Pharma Services LLC	ANDA	Current
69784-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	Woodward Pharma Services LLC	ANDA	Current
69784-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	Woodward Pharma Services LLC	ANDA	Current
69784-180	POLYETHYLENE GLYCOL 3350 NF	polyethylene glycol 3350	Woodward Pharma Services LLC	ANDA	Current