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Last Updated: March 6, 2021

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Details for New Drug Application (NDA): 209381

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NDA 209381 describes PLENVU, which is a drug marketed by Salix and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PLENVU profile page.

The generic ingredient in PLENVU is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate profile page.
Suppliers and Packaging for NDA: 209381
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381 NDA Salix Pharmaceuticals, Inc 65649-400 65649-400-01 1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH
PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381 NDA Salix Pharmaceuticals, Inc 65649-400 65649-400-02 1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH
Paragraph IV (Patent) Challenges for 209381

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM
Approval Date:May 4, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 4, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Sep 10, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 25, 2032Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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