Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021959
Company: CONCORDIA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/01/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021959lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021959TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/08/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/28/2010 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021959s004ltr.pdf
04/27/2009 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021959s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021959s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2010 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf
04/27/2009 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021959s003lbl.pdf
04/27/2009 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021959s003lbl.pdf
06/01/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021959lbl.pdf

ORAPRED ODT

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021959 CONCORDIA PHARMS INC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202179 MYLAN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021959 CONCORDIA PHARMS INC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202179 MYLAN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021959 CONCORDIA PHARMS INC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202179 MYLAN PHARMS INC

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