Application 209381

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLENVUASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATEFOR SOLUTION;ORAL7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209381-001PLENVUASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209381-001107801122032-03-09Drug product2020-09-25
N209381-001107923062032-03-09U-2310Drug product2020-10-13
N209381-001115293682032-03-09U-2310Drug product2023-01-11
N209381-001106465122032-03-25Drug product2020-05-15
N209381-00195922522032-08-11U-2310Drug product2018-05-24
N209381-001100165042033-09-10Drug product2018-07-24
N209381-001109187232033-09-10U-23102021-03-03
N209381-001120831792033-09-10U-2310Drug product2024-09-18
N209381-00189993132033-09-10Drug product2018-05-24
N209381-00193269692033-09-10U-23102018-05-24
N209381-00197072972033-09-10Drug product2018-05-24

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209381-001PLENVU7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMFOR SOLUTION / ORALRLD, RS2018-05-04cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 10 · 384 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209381-001107801122032-03-09Drug product2020-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-001107923062032-03-09U-2310Drug product2020-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-001115293682032-03-09U-2310Drug product2023-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-001106465122032-03-25Drug product2020-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-00195922522032-08-11U-2310Drug product2018-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-001100165042033-09-10Drug product2018-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-001109187232033-09-10U-23102021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-001120831792033-09-10U-2310Drug product2024-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-00189993132033-09-10Drug product2018-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-00193269692033-09-10U-23102018-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209381-00197072972033-09-10Drug product2018-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001107801122032-03-09Drug product2020-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001107923062032-03-09U-2310Drug product2020-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001115293682032-03-09U-2310Drug product2023-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001106465122032-03-25Drug product2020-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-00195922522032-08-11U-2310Drug product2018-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001100165042033-09-10Drug product2018-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001109187232033-09-10U-23102021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-001120831792033-09-10U-2310Drug product2024-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-00189993132033-09-10Drug product2018-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-00193269692033-09-10U-23102018-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209381-00197072972033-09-10Drug product2018-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N209381-001107801122032-03-09Drug product2020-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-001107923062032-03-09U-2310Drug product2020-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-001115293682032-03-09U-2310Drug product2023-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-001106465122032-03-25Drug product2020-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-00195922522032-08-11U-2310Drug product2018-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-001100165042033-09-10Drug product2018-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-001109187232033-09-10U-23102021-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-001120831792033-09-10U-2310Drug product2024-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-00189993132033-09-10Drug product2018-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-00193269692033-09-10U-23102018-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209381-00197072972033-09-10Drug product2018-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001107801122032-03-09Drug product2020-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001107923062032-03-09U-2310Drug product2020-10-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001115293682032-03-09U-2310Drug product2023-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001106465122032-03-25Drug product2020-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-00195922522032-08-11U-2310Drug product2018-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001100165042033-09-10Drug product2018-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209381-001109187232033-09-10U-23102021-03-03fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N209381-001NP2021-05-0474a2ff9319b5…
2021-12-28 21:50 UTC2021-12N209381-001NP2021-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209381-001NP2021-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N209381-001NP2021-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209381-001NP2021-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209381-001NP2021-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209381-001NP2021-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09N209381-001NP2021-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07N209381-001NP2021-05-04ea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc79f930fa-5674-4f30-8ae8-9448d62437972023-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 209381
application number: NDA209381
ndc (product): 65649-400

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUMSalix Pharmaceuticals, InNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75446SUPPL 2023-09-13
75445SUPPL 2023-09-13
75387SUPPL 2023-09-11
67528SUPPL2021-05-18
67527SUPPL2021-05-18
67513SUPPL2021-05-18
58938SUPPL2019-06-04
58885SUPPL2019-05-30
58884SUPPL2019-05-30
58237SUPPL2019-04-05
58234SUPPL2019-04-05
58227SUPPL2019-04-05
56556ORIG2018-11-26
54047ORIG2018-05-08
54033ORIG2018-05-07
54032ORIG2018-05-07