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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 202535


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NDA 202535 describes PREPOPIK, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PREPOPIK profile page.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
Summary for 202535
Paragraph IV (Patent) Challenges for 202535
Tradename Dosage Ingredient NDA Submissiondate
PREPOPIK FOR SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 202535 2014-05-21

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 16, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Free Forever TrialPatent Expiration:Oct 10, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Oct 10, 2028Product Flag?YSubstance Flag?Delist Request?

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