Details for New Drug Application (NDA): 075117
✉ Email this page to a colleague
NDA 075117 describes ORAPRED, which is a drug marketed by Concordia Pharms Inc and is included in two NDAs. Additional details are available on the ORAPRED profile page.
The generic ingredient in ORAPRED is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
The generic ingredient in ORAPRED is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 075117
| Tradename: | ORAPRED |
| Applicant: | Concordia Pharms Inc |
| Ingredient: | prednisolone sodium phosphate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 14, 2000 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
