Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021658
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALVESCO CICLESONIDE 0.08MG/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
ALVESCO CICLESONIDE 0.16MG/INH AEROSOL, METERED;INHALATION Prescription 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
01/10/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/07/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/17/2012 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s006ltr.pdf
11/19/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s005ltr.pdf
12/22/2008 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s002ltr.pdf
10/10/2008 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/17/2012 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf
11/19/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf
12/22/2008 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf
01/10/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf

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