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. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
Summary for 202535
| Tradename: | PREPOPIK |
| Applicant: | Ferring Pharms Inc |
| Ingredient: | citric acid; magnesium oxide; sodium picosulfate |
| Patents: | 2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 16, 2012 | TE: | RLD: | Yes | |||||
| Patent: | 8,450,338 | Patent Expiration: | Oct 10, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,481,083 | Patent Expiration: | Oct 10, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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