Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020929
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PULMICORT RESPULES BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription AN Yes No
PULMICORT RESPULES BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription AN Yes No
PULMICORT RESPULES BUDESONIDE 1MG/2ML SUSPENSION;INHALATION Prescription AN 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
08/08/2000 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20929lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20929ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-929_Pulmicort.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2019 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020929Orig1s052ltr.pdf
08/18/2015 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/10/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

05/15/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

07/02/2010 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020929s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020929s044ltr.pdf
10/05/2009 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020929s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020929s043ltr.pdf
06/15/2007 SUPPL-34 Labeling-Container/Carton Labels

Label is not available on this site.

06/18/2007 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020929s032ltr.pdf
11/20/2006 SUPPL-29 Labeling

Label is not available on this site.

06/30/2005 SUPPL-22 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020929s022ltr.pdf
09/26/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S015_PULMICORT_TURBOHALER_AP.pdf
02/26/2003 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020929s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929se8-013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S013_PULMICORT_RESPULES_AP.pdf
01/10/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929slr012ltr.pdf
07/25/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/24/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2001 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.

04/25/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/2006 SUPPL-2 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020929s002ltr.pdf
02/09/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2019 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf
07/02/2010 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020929s044lbl.pdf
10/05/2009 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020929s043lbl.pdf
09/26/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf
02/26/2003 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020929s013lbl.pdf
08/08/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20929lbl.pdf

PULMICORT RESPULES

SUSPENSION;INHALATION; 0.25MG/2ML
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 205710 CIPLA
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 078404 IMPAX LABS INC
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 078202 NEPHRON
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 201966 SANDOZ INC
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 077519 TEVA PHARMS
PULMICORT RESPULES BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription Yes AN 020929 ASTRAZENECA PHARMS

SUSPENSION;INHALATION; 0.5MG/2ML
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 205710 CIPLA
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 078404 IMPAX LABS INC
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 210897 LUPIN ATLANTIS
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 078202 NEPHRON
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 201966 SANDOZ INC
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 077519 TEVA PHARMS
PULMICORT RESPULES BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription Yes AN 020929 ASTRAZENECA PHARMS

SUSPENSION;INHALATION; 1MG/2ML
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION;INHALATION Prescription No AN 205710 CIPLA
BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION;INHALATION Prescription No AN 201966 SANDOZ INC
BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION;INHALATION Prescription No AN 204548 TEVA PHARMS USA
PULMICORT RESPULES BUDESONIDE 1MG/2ML SUSPENSION;INHALATION Prescription Yes AN 020929 ASTRAZENECA PHARMS

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