Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021959
Company: CONCORDIA PHARMS INC
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 | None | Yes | No |
ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|
03/06/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021959s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021959Orig1s011ltr.pdf | |
07/28/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |
---|---|---|---|---|---|
03/06/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021959s001lbl.pdf | |
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 |