Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022067
Company: SUN PHARMA CANADA
Company: SUN PHARMA CANADA
| 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022067s015lbl.pdf | |
| 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 |