Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020441
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PULMICORT BUDESONIDE 0.16MG/INH POWDER, METERED;INHALATION Discontinued None No No
PULMICORT BUDESONIDE 0.32MG/INH POWDER, METERED;INHALATION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/24/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020441s020ltr.pdf
09/26/2003 SUPPL-18 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/2003/020441_S018_PULMUICORT_TURBUHALER_AP.pdf
12/17/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr017_pulmicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S017_PULMICORT_TURBUHALER_AP.pdf
10/24/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr016_pulmicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S016_PULMICORT_TURBUHALER_AP.pdf
05/18/2001 SUPPL-14 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S014_PULMICORT_TURBUHALER.pdf
07/03/2001 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S013_PULMICORT_TURBUHALER.pdf
12/31/2001 SUPPL-12 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20441s12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S012_Pulmicort Turbuhaler_APPROVAL PACKAGE.pdf
06/18/2001 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S011_PULMICORT_TURBUHALER.pdf
10/15/2001 SUPPL-10 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S010_PULMICORT_TURBUHALER.pdf
12/09/2000 SUPPL-9 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020441_S009_PULMICORT_TURBUHALER.pdf
02/02/2000 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020441_S007_PULMICORT_TURBUHALER.pdf
05/21/1999 SUPPL-5 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020441_S005_PULMICORT_TURBUHALER.pdf
04/12/1999 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020441_S003_PULMICORT_TURBUHALER.pdf
10/08/1998 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20441s2.lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20441s2.ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20441-S002_Pulmicort.cfm
02/11/1998 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020441_S001_PULMICORT_TURBUHALER.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf
12/17/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr017_pulmicort_lbl.pdf
10/24/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr016_pulmicort_lbl.pdf
09/26/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf
10/08/1998 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20441s2.lbl.pdf

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