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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022067
Company: TARO

Summary Review

Products on NDA 022067

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLO-PRED	PREDNISOLONE ACETATE	EQ 5MG BASE/5ML	SUSPENSION;ORAL	Discontinued	None	No	No
FLO-PRED	PREDNISOLONE ACETATE	EQ 15MG BASE/5ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022067_flo-pred_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022067s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022067s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022067Orig1s014ltr.pdf
10/03/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/29/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/28/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/14/2011	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022067s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022067s007ltr.pdf
05/06/2010	SUPPL-4	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022067s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022067s004ltr.pdf
10/03/2008	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s002ltr.pdf
06/27/2008	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s001ltr.pdf

Labels for NDA 022067

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022067s014lbl.pdf
06/14/2011	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022067s007lbl.pdf
05/06/2010	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022067s004lbl.pdf
10/03/2008	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf
10/03/2008	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf
06/27/2008	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf
06/27/2008	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf
01/17/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067lbl.pdf

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