Application 090231

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEG 3350 AND ELECTROLYTES	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	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
A090231-001	PEG 3350 AND ELECTROLYTES	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA		2009-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090231-001	AA

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090231-001	PEG 3350 AND ELECTROLYTES	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	2009-06-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090231-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090231-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090231-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090231-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090231-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090231-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090231-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090231-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090231-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090231-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090231-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090231-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090231-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090231-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090231-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090231-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090231-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090231-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090231-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090231-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090231-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090231-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090231-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090231-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090231-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090231-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090231-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090231-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090231-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090231-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090231-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090231-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090231-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090231-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090231-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090231-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090231-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090231-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090231-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090231-001	AA	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GAVILYTE G TM	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	Lupin Pharmaceuticals,Inc.	3978822b-6473-4072-9f80-20ceb9bea355	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090231 application number: ANDA090231 ndc (product): 43386-090
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	Novel Laboratories, Inc.	29d821ff-389c-41fb-8a27-89bd3f022b82	2023-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090231 application number: ANDA090231 ndc (product): 40032-090

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-090	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	Novel Laboratories, Inc.	ANDA	Current
43386-090	GAVILYTE G	polyethylene glycol-3350 and Electrolytes	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-090	GaviLyte G	polyethylene glycol-3350 and Electrolytes	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-090	GAVILYTE G	polyethylene glycol-3350 and Electrolytes	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-090	GAVILYTE G	polyethylene glycol-3350 and Electrolytes	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-090	GaviLyte G	Polyethylene Glycol-3350 and Electrolytes	GAVIS Pharmaceuticals, LLC	ANDA	Current