Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022051
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLONASE SENSIMIST ALLERGY RELIEF | FLUTICASONE FUROATE | 0.0275MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/15/2023 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022051Orig1s021lbl.pdf | |
| 04/05/2017 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014lbl.pdf | |
| 04/05/2017 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014ltr.pdf | |
| 08/02/2016 | SUPPL-13 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022051Orig1s013lbl.pdf |