Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020833
Company: GLAXO GRP LTD
Company: GLAXO GRP LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLOVENT DISKUS 100 | FLUTICASONE PROPIONATE | 0.1MG/INH | POWDER;INHALATION | Prescription | None | Yes | Yes |
| FLOVENT DISKUS 250 | FLUTICASONE PROPIONATE | 0.25MG/INH | POWDER;INHALATION | Prescription | None | Yes | Yes |
| FLOVENT DISKUS 50 | FLUTICASONE PROPIONATE | 0.05MG/INH | POWDER;INHALATION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020833s034lbl.pdf | |
| 07/19/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020833s033lbl.pdf | |
| 10/05/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s032lbl.pdf | |
| 07/28/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf | |
| 07/28/2016 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf | |
| 04/14/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020833s028lbl.pdf | |
| 05/03/2010 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020833s021lbl.pdf | |
| 09/14/2005 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s015lbl.pdf | |
| 07/31/2005 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s014lbl.pdf | |
| 12/17/2004 | SUPPL-12 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20833s012lbl.pdf |