Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020911
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QVAR 40 BECLOMETHASONE DIPROPIONATE 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AEROSOL, METERED;INHALATION Discontinued None Yes No
QVAR 80 BECLOMETHASONE DIPROPIONATE 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AEROSOL, METERED;INHALATION Discontinued None Yes No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
09/15/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_Qvar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2017 SUPPL-30 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf
09/29/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf
12/16/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/22/2014 SUPPL-26 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Origs026ltr.pdf
07/21/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Orig1s025ltr.pdf
03/09/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/08/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/30/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020911Orig1s022ltr.pdf
08/18/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020911s017ltr.pdf
11/20/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020911s015_ltr.pdf
08/01/2003 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20911slr008ltr.pdf
07/11/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/2002 SUPPL-5 Efficacy-New Patient Population Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20911s005ltr.pdf
08/02/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/27/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2001 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
09/29/2017 SUPPL-30 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf
09/29/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf
09/29/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf
07/21/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf
05/22/2014 SUPPL-26 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf
07/30/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf
08/18/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf
11/20/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf
09/15/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf

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