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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. Two 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 NDA: 021881

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 Physicians Total Care, Inc. 54868-5890 54868-5890-0 1 KIT in 1 CONTAINER (54868-5890-0) * 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 65649-201-75 1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Approval Date:Aug 2, 2006TE:RLD:Yes
Patent:7,169,381Patent Expiration:Sep 1, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:7,658,914Patent Expiration:Sep 1, 2024Product Flag?YSubstance Flag?YDelist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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