Application 209381

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLENVU	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	FOR SOLUTION;ORAL	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N209381-001	PLENVU	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION / ORAL		RLD	2018-05-04

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209381-001	10780112	2032-03-09		Drug product	2020-09-25
N209381-001	10792306	2032-03-09	U-2310	Drug product	2020-10-13
N209381-001	11529368	2032-03-09	U-2310	Drug product	2023-01-11
N209381-001	10646512	2032-03-25		Drug product	2020-05-15
N209381-001	9592252	2032-08-11	U-2310	Drug product	2018-05-24
N209381-001	10016504	2033-09-10		Drug product	2018-07-24
N209381-001	10918723	2033-09-10	U-2310		2021-03-03
N209381-001	12083179	2033-09-10	U-2310	Drug product	2024-09-18
N209381-001	8999313	2033-09-10		Drug product	2018-05-24
N209381-001	9326969	2033-09-10	U-2310		2018-05-24
N209381-001	9707297	2033-09-10		Drug product	2018-05-24

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N209381-001	PLENVU	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION / ORAL	RLD, RS	2018-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209381-001	PLENVU	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION / ORAL	RLD, RS	2018-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209381-001	PLENVU	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION / ORAL	RLD, RS	2018-05-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209381-001	PLENVU	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION / ORAL	RLD, RS	2018-05-04	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 417 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209381-001	10780112	2032-03-09		Drug product	2020-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	10792306	2032-03-09	U-2310	Drug product	2020-10-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	11529368	2032-03-09	U-2310	Drug product	2023-01-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	10646512	2032-03-25		Drug product	2020-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	9592252	2032-08-11	U-2310	Drug product	2018-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	10016504	2033-09-10		Drug product	2018-07-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	10918723	2033-09-10	U-2310		2021-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	12083179	2033-09-10	U-2310	Drug product	2024-09-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	8999313	2033-09-10		Drug product	2018-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	9326969	2033-09-10	U-2310		2018-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209381-001	9707297	2033-09-10		Drug product	2018-05-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209381-001	10780112	2032-03-09		Drug product	2020-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	10792306	2032-03-09	U-2310	Drug product	2020-10-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	11529368	2032-03-09	U-2310	Drug product	2023-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	10646512	2032-03-25		Drug product	2020-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	9592252	2032-08-11	U-2310	Drug product	2018-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	10016504	2033-09-10		Drug product	2018-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	10918723	2033-09-10	U-2310		2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	12083179	2033-09-10	U-2310	Drug product	2024-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	8999313	2033-09-10		Drug product	2018-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	9326969	2033-09-10	U-2310		2018-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209381-001	9707297	2033-09-10		Drug product	2018-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209381-001	10780112	2032-03-09		Drug product	2020-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	10792306	2032-03-09	U-2310	Drug product	2020-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	11529368	2032-03-09	U-2310	Drug product	2023-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	10646512	2032-03-25		Drug product	2020-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	9592252	2032-08-11	U-2310	Drug product	2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	10016504	2033-09-10		Drug product	2018-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	10918723	2033-09-10	U-2310		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	12083179	2033-09-10	U-2310	Drug product	2024-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	8999313	2033-09-10		Drug product	2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	9326969	2033-09-10	U-2310		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209381-001	9707297	2033-09-10		Drug product	2018-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209381-001	10780112	2032-03-09		Drug product	2020-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209381-001	10792306	2032-03-09	U-2310	Drug product	2020-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209381-001	11529368	2032-03-09	U-2310	Drug product	2023-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209381-001	10646512	2032-03-25		Drug product	2020-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209381-001	9592252	2032-08-11	U-2310	Drug product	2018-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209381-001	10016504	2033-09-10		Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209381-001	10918723	2033-09-10	U-2310		2021-03-03	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209381-001	NP	2021-05-04	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209381-001	NP	2021-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209381-001	NP	2021-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209381-001	NP	2021-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209381-001	NP	2021-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209381-001	NP	2021-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209381-001	NP	2021-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209381-001	NP	2021-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209381-001	NP	2021-05-04	`ea99ee380514…`

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
Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	79f930fa-5674-4f30-8ae8-9448d6243797	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209381 application number: NDA209381 ndc (product): 65649-400

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM	Salix Pharmaceuticals, In	NDA	Current
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	NDA	Current
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	NDA	Current
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	NDA	Current
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	NDA	Current
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	NDA	Current
65649-400	Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	Salix Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75446	SUPPL	2023-09-13
75445	SUPPL	2023-09-13
75387	SUPPL	2023-09-11
67528	SUPPL	2021-05-18
67527	SUPPL	2021-05-18
67513	SUPPL	2021-05-18
58938	SUPPL	2019-06-04
58885	SUPPL	2019-05-30
58884	SUPPL	2019-05-30
58237	SUPPL	2019-04-05
58234	SUPPL	2019-04-05
58227	SUPPL	2019-04-05
56556	ORIG	2018-11-26
54047	ORIG	2018-05-08
54033	ORIG	2018-05-07
54032	ORIG	2018-05-07