Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020746
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RHINOCORT | BUDESONIDE | 0.032MG/INH | SPRAY, METERED;NASAL | Prescription | AB | Yes | No |
| RHINOCORT | BUDESONIDE | 0.064MG/INH | SPRAY, METERED;NASAL | Discontinued | None | No | No |
| RHINOCORT ALLERGY | BUDESONIDE | 0.032MG/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 |
|---|---|---|---|---|---|
| 05/22/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020746Orig1s037lbl.pdf | |
| 08/24/2016 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s036lbl.pdf | |
| 04/22/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s034lbl.pdf | |
| 03/10/2016 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s033lbl.pdf | |
| 03/23/2015 | SUPPL-32 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032.pdf | |
| 12/28/2010 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf | |
| 05/21/2009 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020746s024lbl.pdf | |
| 10/16/2007 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020746s021lbl.pdf | |
| 08/25/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746s015lbl.pdf | |
| 01/16/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746slr013_rhinocort_lbl.pdf | |
| 09/26/2003 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf | |
| 10/01/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20746lbl.pdf |