Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020746
Company: ASTRAZENECA PHARMS
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.cfm
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-Labeling Change With Clinical Data 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-Labeling Change With Clinical Data 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 ASTRAZENECA PHARMS

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 INC
RHINOCORT ALLERGY BUDESONIDE 0.032MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 020746 ASTRAZENECA PHARMS

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