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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/01/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20746lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20746ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20746_Rhinocort.html |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020746Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020746Orig1s037ltr.pdf | |
| 08/24/2016 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s036ltr.pdf | |
| 03/02/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s034ltr.pdf | |
| 03/10/2016 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s033ltr.pdf | |
| 03/23/2015 | SUPPL-32 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020746Orig1s032ltr.pdf | |
| 04/29/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/2010 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020746s026ltr.pdf | |
| 05/21/2009 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020746s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020746s024ltr.pdf | |
| 10/16/2007 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020746s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020746s021ltr.pdf | |
| 07/30/2004 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s016ltr.pdf |
| 08/25/2004 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s015ltr.pdf | |
| 01/16/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746slr013_rhinocort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746slr013ltr.pdf | |
| 09/26/2003 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf | |
| 10/03/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/2001 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20746s4ltr.pdf |
| 06/25/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| 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 |
RHINOCORT
SPRAY, METERED;NASAL; 0.032MG/INH
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RHINOCORT | BUDESONIDE | 0.032MG/INH | SPRAY, METERED;NASAL | Prescription | Yes | AB | 020746 | KENVUE BRANDS |
RHINOCORT ALLERGY
There are no Therapeutic Equivalents.
RHINOCORT
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
RHINOCORT ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 0.032MG/SPRAY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 078949 | APOTEX |
| RHINOCORT ALLERGY | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 020746 | KENVUE BRANDS |