Application 021881

Type: NDA
Sponsor: SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOVIPREP	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	FOR SOLUTION;ORAL	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	Yes	Yes

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
N021881-001	MOVIPREP	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021881-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL		RLD, RS	2006-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL		RLD, RS	2006-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL		RLD, RS	2006-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021881-001	MOVIPREP	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	RLD, RS	2006-08-02	`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	N021881-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021881-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021881-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021881-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021881-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021881-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021881-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021881-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021881-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021881-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021881-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021881-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021881-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021881-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021881-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021881-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021881-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021881-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021881-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021881-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021881-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021881-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021881-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021881-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021881-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021881-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021881-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021881-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021881-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021881-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021881-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021881-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021881-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021881-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021881-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021881-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021881-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021881-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021881-001	7169381	2024-09-01	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021881-001	7658914	2024-09-01	Drug substance, Drug product	`3f01610625f2…`

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
MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	8ff46193-2a3b-4de0-9572-775dda8cd8b2	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021881 application number: NDA021881 ndc (product): 65649-201
PEG-3350, Electrolytes, and Ascorbate	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE, AND ASCORBIC ACID	Oceanside Pharmaceuticals	cd9c0751-10fa-4f5f-bf29-742823541d22	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021881 application number: NDA021881 ndc (product): 68682-201

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
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
65649-201	MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc.	NDA	Current
68682-201	PEG-3350, Electrolytes, and Ascorbate	polyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-201	PEG-3350, Electrolytes, and Ascorbate	polyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70740	SUPPL	2022-04-11
70732	SUPPL	2022-04-08
67526	SUPPL	2021-05-18
67525	SUPPL	2021-05-18
65149	SUPPL	2020-11-04
60785	SUPPL	2019-11-06
56828	SUPPL	2018-12-20
56758	SUPPL	2018-12-17
56757	SUPPL	2018-12-17
37820	SUPPL	2013-12-19
28774	SUPPL	2013-12-19
23311	ORIG	2013-09-20
37819	SUPPL	2013-09-17
28773	SUPPL	2013-09-13
37818	SUPPL	2012-08-31
6377	SUPPL	2012-08-30
6375	SUPPL	2011-05-03
37816	SUPPL	2011-04-29
6376	SUPPL	2010-11-04
37817	SUPPL	2010-11-02
21856	ORIG	2008-09-05
28772	SUPPL	2008-02-07
6374	ORIG	2006-08-07
37815	ORIG	2006-08-04