Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022067
Company: TARO
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
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
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-Package Insert, Labeling-Container/Carton Labels 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-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf
10/03/2008 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf
06/27/2008 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf
06/27/2008 SUPPL-1 Labeling-Container/Carton Labels 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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