Details for New Drug Application (NDA): 021881

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NDA 021881 describes MOVIPREP, which is a drug marketed by Salix Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOVIPREP profile page.

The generic ingredient in MOVIPREP 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.

Summary for 021881

Tradename:	MOVIPREP
Applicant:	Salix Pharms
Ingredient:	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate
Patents:	2

Suppliers and Packaging for NDA: 021881

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881	NDA	Salix Pharmaceuticals, Inc.	65649-201	65649-201-75	1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH
MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881	NDA	Salix Pharmaceuticals, Inc.	65649-201	65649-201-76	1 KIT in 1 CONTAINER (65649-201-76) * 1 L in 1 POUCH * 1 L in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Approval Date:	Aug 2, 2006	TE:	AA	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 1, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 1, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021881

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006	⤷ Sign Up	⤷ Sign Up
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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