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Generated: June 19, 2019

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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. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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. Twenty-two suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 017473
Formulation / Manufacturing:see details
Pharmacology for NDA: 017473
Medical Subject Heading (MeSH) Categories for 017473
Suppliers and Packaging for NDA: 017473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORAP pimozide TABLET;ORAL 017473 NDA Teva Select Brands 57844-151 57844-151-01 100 TABLET in 1 BOTTLE (57844-151-01)
ORAP pimozide TABLET;ORAL 017473 NDA Teva Select Brands 57844-198 57844-198-01 100 TABLET in 1 BOTTLE (57844-198-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 31, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 27, 1997TE:ABRLD:Yes

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