Application 090019

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	FOR SOLUTION;ORAL	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/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
A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA		2009-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090019-001	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	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090019-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090019-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090019-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090019-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090019-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090019-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090019-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090019-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090019-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090019-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090019-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090019-001	AA	1	`301d65b070ca…`
2019-12-13 00:20 UTC	2019-12	A090019-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090019-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090019-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090019-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090019-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090019-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090019-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090019-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090019-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090019-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090019-001	AA	1	`a50c72e98297…`

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
GAVILYTE-N	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE	Lupin Pharmaceuticals,Inc.	27195187-75a3-431f-90d9-84da1b94e849	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090019 application number: ANDA090019 ndc (product): 43386-050

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-050	Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate	Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate	Novel Laboratories, Inc.	ANDA	Current
43386-050	GaviLyte - N	polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate	Lupin Pharmaceuticals,Inc.	ANDA	Current