Details for New Drug Application (NDA): 017473
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NDA 017473 describes ORAP, which is a drug marketed by Teva and Concordia Pharms Inc and is included in three NDAs. Additional details are available on the ORAP profile page.
The generic ingredient in ORAP is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
The generic ingredient in ORAP is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 017473
| Tradename: | ORAP |
| Applicant: | Teva |
| Ingredient: | pimozide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 017473
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 31, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 27, 1997 | TE: | RLD: | Yes | |||||
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