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FDA Drug Approval, N202535, PREPOPIK
FDA Drug Approval, N202535, PREPOPIK
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NDA: 202535
Company: FERRING PHARMS INC
Drug Name: PREPOPIK
Active Ingredients: CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Strength: 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: FOR SOLUTION;ORAL
Action Date: 07/16/2012
Marketing Status: Discontinued
Submission Classification: Type 1 - New Molecular Entity
Company: FERRING PHARMS INC
Drug Name: PREPOPIK
Active Ingredients: CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Strength: 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: FOR SOLUTION;ORAL
Action Date: 07/16/2012
Marketing Status: Discontinued
Submission Classification: Type 1 - New Molecular Entity
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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