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Last Updated: December 13, 2019

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Details for New Drug Application (NDA): 021959

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NDA 021959 describes ORAPRED ODT, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ORAPRED ODT profile page.

The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 021959
Tradename:ORAPRED ODT
Applicant:Concordia Pharms Inc
Ingredient:prednisolone sodium phosphate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021959
Suppliers and Packaging for NDA: 021959
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959 NDA Concordia Pharmaceuticals Inc. 59212-700 59212-700-48 8 BLISTER PACK in 1 CARTON (59212-700-48) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959 NDA Concordia Pharmaceuticals Inc. 59212-701 59212-701-02 1 BLISTER PACK in 1 CARTON (59212-701-02) > 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021959
Tradename Dosage Ingredient NDA Submissiondate
ORAPRED ODT TABLET, ORALLY DISINTEGRATING;ORAL prednisolone sodium phosphate 021959 2010-07-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Jun 1, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 24, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 15MG BASE
Approval Date:Jun 1, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 24, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 30MG BASE
Approval Date:Jun 1, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 24, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021959

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006   Start Trial   Start Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006   Start Trial   Start Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006   Start Trial   Start Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006   Start Trial   Start Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006   Start Trial   Start Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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