Application 019011

Type: NDA
Sponsor: BRAINTREE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GOLYTELY	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	Yes	Yes
002	GOLYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	Yes	No

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
N019011-001	GOLYTELY	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	RLD, RS	1984-07-13
N019011-002	GOLYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019011-001	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 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	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD, RS	1992-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`782e0a99824c…`

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	N019011-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019011-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019011-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019011-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019011-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019011-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019011-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019011-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019011-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019011-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019011-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019011-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019011-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019011-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019011-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019011-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019011-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019011-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019011-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019011-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019011-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019011-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019011-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019011-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019011-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019011-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019011-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019011-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019011-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019011-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019011-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019011-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019011-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019011-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019011-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019011-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019011-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019011-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019011-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019011-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	19daf830-7270-4661-81b1-ded38f867f28	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Wilshire Pharmaceuticals, Inc.	b251752d-7750-482a-9364-0acf4ad47cc8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Azurity Pharmaceuticals, Inc.	7609ecf7-0ce0-4fbb-9c27-30987f689575	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Affordable Pharmaceuticals, LLC	448db7a5-1fea-4bf3-b1f5-e9d027a36603	2022-09-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011 ndc (product): 10572-100 ndc (product): 10572-101
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Braintree Laboratories, Inc.	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	2021-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011 ndc (product): 52268-101 ndc (product): 52268-700 ndc (product): 52268-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10572-100	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-100	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-100	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-100	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-101	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-101	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-101	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-101	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
52268-100	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-100	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-100	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-100	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-101	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-101	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-101	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-101	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-700	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-700	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-700	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current
52268-700	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	Braintree Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67522	SUPPL	2021-05-18
67521	SUPPL	2021-05-18
67493	SUPPL	2021-05-17
63577	SUPPL	2020-06-16
63450	SUPPL	2020-06-08
63449	SUPPL	2020-06-08
63447	SUPPL	2020-06-08
43617	ORIG	2013-10-03
16170	SUPPL	2013-09-24
33687	SUPPL	2013-09-23
16169	SUPPL	2002-09-19