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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021959
Company: ADVANZ PHARMA

Products on NDA 021959

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021959

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021959s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021959Orig1s014ltr.pdf
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.
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-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 021959

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021959s014lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021959s003lbl.pdf
04/27/2009	SUPPL-3	Labeling-Container/Carton Labels	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

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