Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020950
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUONEB ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION Discontinued None Yes No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
03/21/2001 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/29/2012 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020950s037ltr.pdf
03/03/2011 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020950s032ltr.pdf
09/26/2005 SUPPL-18 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020950s018ltr.pdf
06/02/2006 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020950s012LTR.pdf
12/10/2002 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/20/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2001 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
05/29/2012 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf
03/03/2011 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf
03/21/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf

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