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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020441
Company: ASTRAZENECA

Products on NDA 020441

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020441

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

Labels for NDA 020441

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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