Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021457
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROAIR HFA ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription BX 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
10/29/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21457ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021457s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/2019 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021457Orig1s036ltr.pdf
05/20/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/08/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/23/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/09/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/10/2012 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/07/2012 SUPPL-26 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf
12/10/2010 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/08/2010 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s022ltr.pdf
08/17/2010 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s021ltr.pdf
09/16/2008 SUPPL-13 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021457s013ltr.pdf
11/21/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf
02/03/2006 SUPPL-3 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf
11/21/2005 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf
05/02/2005 SUPPL-1 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/25/2019 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf
03/07/2012 SUPPL-26 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf
08/17/2010 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf
09/16/2008 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf
02/03/2006 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf
11/21/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf
11/21/2005 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf
05/02/2005 SUPPL-1 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf
10/29/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf

PROAIR HFA

There are no Therapeutic Equivalents.

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