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Last Updated: November 24, 2024

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. Fifteen 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
Medical Subject Heading (MeSH) Categories for 017473

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 31, 1984TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 27, 1997TE:RLD:Yes

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