Application 019797

Type: NDA
Sponsor: BRAINTREE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	FOR SOLUTION;ORAL	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	Yes	Yes
002	NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	FOR SOLUTION;ORAL	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019797-001	NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22
N019797-002	NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019797-001	AA
N019797-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019797-001	NULYTELY	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1991-04-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019797-002	NULYTELY-FLAVORED	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1994-11-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N019797-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019797-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019797-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019797-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019797-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019797-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019797-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019797-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019797-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019797-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019797-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019797-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019797-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019797-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019797-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019797-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019797-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019797-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019797-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019797-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019797-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019797-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019797-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019797-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019797-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019797-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019797-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019797-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019797-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019797-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019797-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019797-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019797-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019797-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019797-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019797-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019797-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019797-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019797-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019797-002	AA	1	`782e0a99824c…`

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
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride	POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE	Wilshire Pharmaceuticals, Inc.	4e442a72-b13b-4869-8a1d-59356095b091	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019797 application number: NDA019797
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE	Affordable Pharmaceuticals, LLC	89ca6d56-527a-4be2-baea-531156f0a7be	2021-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019797 application number: NDA019797 ndc (product): 10572-302

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10572-302	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-302	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-302	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-400	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
52268-302	NuLYTELY	polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-302	NuLYTELY	polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-302	NuLYTELY	polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-400	NuLYTELY With Flavor Packs	Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-400	NuLYTELY With Flavor Packs	Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-400	NuLYTELY With Flavor Packs	Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67524	SUPPL	2021-05-18
67494	SUPPL	2021-05-17
43625	ORIG	2013-10-03
19227	SUPPL	2013-09-24
11724	SUPPL	2013-09-23
1627	SUPPL	2004-06-18